title: A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

summary: This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

ReferenceCitation: Antoñanzas F, Brenes F, Molero JM, Fernández-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.

ReferenceCitation: Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.

ReferenceCitation: Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.

ReferenceCitation: Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.

ReferenceCitation: Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.

ReferenceCitation: Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19. Erratum in: Eur Urol. 2010 Nov;58(5):801.

ReferenceCitation: Roehrborn CG, Andriole GL, Wilson TH, Castro R, Rittmaster RS. Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial. Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.

ReferenceCitation: Roehrborn CG, Barkin J, Siami P, Tubaro A, Wilson TH, Morrill BB, Gagnier RP. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial. BJU Int. 2011 Mar;107(6):946-54. doi: 10.1111/j.1464-410X.2011.10124.x. Epub 2011 Feb 18.

ReferenceCitation: Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. 2012 May;187(5):1732-8. doi: 10.1016/j.juro.2011.12.083. Epub 2012 Mar 15.

ReferenceCitation: Becher E, Roehrborn CG, Siami P, Gagnier RP, Wilson TH, Montorsi F. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study. Prostate Cancer Prostatic Dis. 2009;12(4):369-74. doi: 10.1038/pcan.2009.37. Epub 2009 Sep 1.

ReferenceCitation: Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJU Int. 2011 May;107(9):1426-31. doi: 10.1111/j.1464-410X.2011.10129.x. Epub 2011 Feb 23.

ReferenceCitation: Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract. 2010 Jul;64(8):1042-51. doi: 10.1111/j.1742-1241.2010.02428.x. Epub 2010 May 7.

ReferenceCitation: Haillot O, Fraga A, Maciukiewicz P, Pushkar D, Tammela T, Höfner K, Chantada V, Gagnier P, Morrill B. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):302-6. doi: 10.1038/pcan.2011.13. Epub 2011 Apr 19.

ReferenceCitation: Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. Epub 2007 Dec 21. Erratum in: J Urol. 2008 Sep;180(3):1191.

location_country:
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
France
Poland
Lithuania
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Netherlands
Philippines
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Tunisia
Spain
Estonia


title: Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL

summary: The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Döhner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.

name: Roche Pharma Research and Early Development, Penzberg, Germany;

family: Weisser

full_name: Martin Weisser

given: Martin

sequence: first

name: Biostatistics, Genentech Inc., South San Francisco, CA;

family: Yeh

full_name: Ru-Fang Yeh

given: Ru-Fang

sequence: additional

name: F. Hoffman–La Roche Ltd., Basel, Switzerland;

family: Duchateau-Nguyen

full_name: Guillemette Duchateau-Nguyen

given: Guillemette

family: Palermo

full_name: Giuseppe Palermo

given: Giuseppe

family: Nguyen

full_name: Tri Quang Nguyen

given: Tri Quang

name: Molecular Diagnostics and Cancer Cell Biology, Genentech Inc., South San Francisco, CA;

family: Shi

full_name: Xiaoyan Shi

given: Xiaoyan

family: Stinson

full_name: Susanna Y. Stinson

given: Susanna Y.

family: Yu

full_name: Nancy Yu

given: Nancy

name: Laboratory for Leukemia Diagnostics, Ludwig Maximilians University, Munich, Germany;

family: Dufour

full_name: Annika Dufour

given: Annika

name: Department of Haematology, Medical University, Lodz, Poland;

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

name: Hematology Department, Saint Petersburg Pavlov State Medical University, Saint Petersburg, Russia;

family: Salogub

full_name: Galina N. Salogub

given: Galina N.

name: Haematooncology and Bone Marrow Transplantation Department, Medical University, Lublin, Poland;

family: Dmoszynska

full_name: Anna Dmoszynska

given: Anna

name: Department of Hematology, Institut de Cancérologie de l'Ouest, Nantes, France;

family: Solal-Celigny

full_name: Philippe Solal-Celigny

given: Philippe

name: Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland;

family: Warzocha

full_name: Krzysztof Warzocha

given: Krzysztof

name: Department of Hematology, Hospital Universitario de La Princesa, IIS-IP, Madrid, Spain;

family: Loscertales

full_name: Javier Loscertales

given: Javier

name: Dorevitch Pathology Laboratory, Frankston Hospital, Frankston, Australia;

family: Catalano

full_name: John Catalano

given: John

name: Division of Clinical Hematology, Walter C. Mackenzie Health Sciences Centre, Edmonton, AB, Canada;

family: Larratt

full_name: Loree Larratt

given: Loree

name: Haematology Department, Samara Region Clinical Hospital, Samara, Russia;

family: Rossiev

full_name: Viktor A. Rossiev

given: Viktor A.

name: Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada;

family: Bence-Bruckler

full_name: Isabelle Bence-Bruckler

given: Isabelle

family: Geisler

full_name: Christian H. Geisler

given: Christian H.

name: Department of Haematology & Oncology, Division of Haematology, Ospedale Niguarda Ca' Granda, Milan, Italy;

family: Montillo

full_name: Marco Montillo

given: Marco

name: Department I of Internal Medicine and Centre for Integrated Oncology, University of Cologne, Cologne, Germany;

family: Fischer

full_name: Kirsten Fischer

given: Kirsten

family: Fink

full_name: Anna-Maria Fink

given: Anna-Maria

name: Department of Internal Medicine III, University of Ulm, Ulm, Germany;

name: Institute for Medical Statistics and Epidemiology, Technical University of Munich, Munich, Germany;

name: Division of Biostatistics, German Cancer Research Center, Heidelberg, Germany;

name: BioOncology, Genentech Inc., South San Francisco, CA; and

name: Pharmaceuticals Division, F. Hoffmann–La Roche Ltd., Basel, Switzerland

ReferenceCitation: Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.

name: Laboratory for Leukemia Diagnostics, Department of Medicine III, Grosshadern Hospital, Ludwig-Maximilians-University, Munich, Germany;

name: Roche Pharma Research and Early Development, Basel, Switzerland;

name: Centre for Human Genetics, Philipps University, Marburg, Germany;

name: Department of Oncology and Hematology, Hospital Barmherzige Brüder, Regensburg, Germany;

name: Roche Molecular Systems, Pleasanton, CA;

name: Roche Applied Science, Penzberg, Germany;

name: Genentech Research and Early Development, South San Francisco, CA;

name: Hematology Department of St. Petersburg, Pavlov State Medical University, St. Petersburg, Russia;

name: Centre Jean Bernard, Clinique Victor Hugo, Le Mans, France;

name: Hematooncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland;

name: Department of Haematology, Medical University of Lodz, Lodz, Poland;

name: Division of Hematology, Niguarda Cà Granda Hospital, Milan, Italy;

name: Department of Hematology, Rigshospitalet, Copenhagen, Denmark; and

location_country:
Italy
United States
Sweden
Netherlands
Spain
France
Poland
Norway
Hungary
Belgium
Australia
New Zealand
Romania
Russian Federation
Denmark
Canada
United Kingdom

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

location_facility: Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases

location_facility: Pinderfields General Hospital; Dept of Haematology

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Klin. Chorob Wewnetrznych I Hemat. Z Osrodkiem Transplant. Szpiku

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Regional Clinical Hospital; Hematology Dept. #2 For B M Transplantation & High Dose Chemo.

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: Christchurch Hospital; Canterbury Health Laboratories

location_facility: Universitetssjukhuset i Linköping, Hematologkliniken

location_facility: The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704

location_facility: Pacific Coast Hematology/Oncology Medical Group

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA

location_facility: Haematology Research Center; Haematology

location_facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Royal Marsden Hospital; Academic Dept of Haematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Chu La Miletrie; Hdj Cons Hemato Cancerologie

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: State Medical Inst. Municipal Hospital #31; Oncology & Hematology Dept. With the Usechemo. in Adult

location_facility: Instytut Hematologii I Transfuzjologii; Klinika Chorob Wewnetrznych I Hematologii

location_facility: Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Haukeland Universitetshospital; Medicine Dept

location_facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Uni of Debrecen; 2Nd Clinic of Internal Medicine

location_facility: Hopital Clemenceau; Hematologie Clinique

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre; Hematology

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: University of Szeged, II Dept of Internal Medicine

location_facility: Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

location_facility: Mater Hospital; Division of Cancer Services

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: Rush-Presbyterian St. Luke'S Medical Center

location_facility: Hopital Avicenne; Hematologie Biologique

location_facility: Országos Gyógyintézeti Központ; Haematologiai Osztaly

location_facility: Wellington Hospital; Regional Oncology Unit

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Research Inst. Hematology /Blood Transfusion ; Hemablastosis, Supression Hemopoesis & B M Transplant

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Ospedale S. Eugenio; Divisione Di Ematologia

location_facility: Akademii Medycznej W; Klinika Hematologii

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Karolinska Inst. , Huddinge Uni Hospital; Depart. of Hematology

location_facility: S.-Peterburg Pavlov State Medical University ; Haematology

location_facility: California Cancer Center Woodward Park; Community Medical Centers

location_facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

location_facility: St. Bartholomew'S Hospital; Dept of Medical Oncology

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Hopital Edouard Herriot; Bat.E-Hematologie

location_facility: City Clinical Botkin's Hospital; City Hematological Center

location_facility: Regional Clinical Hospital N.A. Kalinin; Hematology Dept

location_facility: Academisch Medisch Centrum Universiteit Amsterdam

location_facility: Milton S. Hershey Medical Center; Penn State Cancer Inst.

location_facility: Medical University School; Dept. of Haematology

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: Peter Maccallum Cancer Institute; Medical Oncology


title: A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults

summary: The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
India
France
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

summary: This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

lead_sponsor: Hoffmann-La Roche

location_country:
Guatemala
Finland
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
France
Panama
Thailand
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Switzerland
Hungary
Ireland
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

intervention_type: Drug


title: Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer

summary:
RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

ReferenceType: result

ReferenceCitation: Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010 Oct 10;28(29):4450-6. doi: 10.1200/JCO.2010.30.3446. Epub 2010 Sep 13.

name: From the Erasme University Hospital, Brussels; Algemeen Ziekenhuis Groeninge, Kortrijk; Universitair Ziekenhuis Ghent, Ghent; Centre Hospitalier Universitaire (CHU) de Liège Domaine Universitaire du Sart Tilman, Liège; European Organisation for Research and Treatment of Cancer Headquarters, Brussels; University Hospital Gasthuisberg, Leuven, Belgium; Hôpital Beaujon, Clichy-la-Garenne; CHU du Lyon, Lyon; Centre Régional de Lutte contre le Cancer Val d'Aurelle, Montpellier, France; Academisch Medisch...

family: Van Laethem

full_name: Jean-Luc Van Laethem

given: Jean-Luc

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Mornex

full_name: Françoise Mornex

given: Françoise

family: Azria

full_name: David Azria

given: David

family: Van Tienhoven

full_name: Geertjan Van Tienhoven

given: Geertjan

family: Vergauwe

full_name: Philippe Vergauwe

family: Peeters

full_name: Marc Peeters

given: Marc

family: Polus

full_name: Marc Polus

family: Praet

full_name: Michel Praet

given: Michel

family: Mauer

full_name: Murielle Mauer

given: Murielle

family: Collette

full_name: Laurence Collette

given: Laurence

family: Budach

full_name: Volker Budach

given: Volker

family: Lutz

full_name: Manfred Lutz

given: Manfred

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Haustermans

full_name: Karin Haustermans

given: Karin

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher: American Society of Clinical Oncology (ASCO)

title: Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study

ReferenceCitation: Van Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Switzerland Netherlands France Israel Belgium Germany

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

intervention_type: Radiation


title: An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options

summary: To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.

status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
South Africa
Switzerland
France
Greece
Ireland
Belgium
Australia
Portugal
Denmark
United States
United Kingdom

location_facility: 1182.58.44010 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61013 Melbourne Sexual Health Clinic

location_facility: 1182.58.44027 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.06 University of Cincinnati Medical Center, Infectious diseases

location_facility: 1182.58.33017 Hôpital Bichat Claude Bernard

location_facility: 1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine

location_facility: 1182.58.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27096 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44029 Our Lady For Sick Children

location_facility: 1182.58.27095 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.4101 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61018 Melbourne Sexual Health Clinic

location_facility: 1182.58.27099 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44008 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44005 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44002 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44003 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61001 88 Rathdowne Street Carlton

location_facility: 1182.58.039 Olmos Park Medical Associates

location_facility: 1182.58.44011 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.04 Kansas City Free Health Clinic

location_facility: 1182.58.61017 Department of Infectious Diseases

location_facility: 1182.58.61016 Princess Alexandra Hospital

location_facility: 1182.58.61002 Royal North Shore Hospital

location_facility: 1182.58.4505 Aarhus Universitetshospital Skejby

location_facility: 1182.58.44017 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44018 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.40 Drs. Raben and Feldman Research Associates

location_facility: 1182.58.4103 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.18 University of Texas Southwest Medical Center at Dallas

location_facility: 1182.58.4105 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.4102 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44025 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44022 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61005 Royal Prince Alfred Hospital

location_facility: 1182.58.3203 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27098 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44004 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44014 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44023 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44030 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27097 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61003 The Prince of Wales Hospital

location_facility: 1182.58.3201 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: 1182.58.44026 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44028 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.35102 Hospital Condes Castro Guimarães

location_facility: 1182.58.3906 Ospedale Infantile Regina Margherita

location_facility: 1182.58.4104 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44031 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.01 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.3907 Presidio Ospedaliero di Rimini

location_facility: 1182.58.4107 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44019 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.23 Hillsborough County Health Department

location_facility: 1182.58.44024 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.3204 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44009 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


ReferenceType: background

ReferenceCitation: Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Díez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barberà J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.

ReferenceCitation: Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.

ReferenceCitation: Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.

ReferenceCitation: Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.

ReferenceCitation: Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barberà J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.

ReferenceCitation: Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.

family: Kim

full_name: Joon Hyung Kim

given: Joon Hyung

family: Diaz-Decaro

full_name: John Diaz-Decaro

given: John

family: Jiang

full_name: Ning Jiang

given: Ning

name: Department of Family Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan

name: National Yang Ming University School of Medicine, Taipei City, Taiwan

family: Hwang

full_name: Shinn-Jang Hwang

given: Shinn-Jang

name: Department of Infectious Diseases, SoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea

family: Choo

full_name: Eun Ju Choo

given: Eun Ju

family: Co

full_name: Maribel Co

given: Maribel

family: Hastie

full_name: Andrew Hastie

given: Andrew

name: Department of Medicine and Therapeutics, The Chinese University of Hong Kong Prince of Wales Hospital, Sha Tin, Hong Kong

family: Hui

full_name: David Shu Cheong Hui

given: David Shu Cheong

name: Department of Dermatology, Shonan Kamakura General Hospital, Kanagawa, Japan

family: Irimajiri

full_name: Junya Irimajiri

given: Junya

name: Department of Internal Medicine, Division of Infectious Diseases, Kangnam Sacred Heart Hospital, Seoul, Republic of Korea

family: Lee

full_name: Jacob Lee

given: Jacob

name: Department of Medicine and Geriatrics, Division of Geriatric Medicine and Rehabilitation, United Christian Hospital, Kwun Tong, Hong Kong

family: Leung

full_name: Edward Man-Fuk Leung

given: Edward Man-Fuk

family: Tang

full_name: Haiwen Tang

given: Haiwen

name: Medical CO.LTA PS Clinic, Fukuoka, Japan

family: Tsuru

full_name: Tomomi Tsuru

given: Tomomi

family: Watson

full_name: Philip Watson

given: Philip

family: Wu

full_name: Zhenhua Wu

given: Zhenhua

name: Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan

name: National Taiwan University Hospital Biomedical Park Branch Hospital, Zhubei City, Hsinchu County, Taiwan

family: Yu

full_name: Chong-Jen Yu

given: Chong-Jen

family: Yuan

full_name: Yanfei Yuan

given: Yanfei

family: Zahaf

full_name: Toufik Zahaf

given: Toufik

name: The Westmead Institute for Medical Research, Westmead, Australia

family: Cunningham

full_name: Anthony L. Cunningham

given: Anthony L.

family: Schuind

full_name: Anne Schuind

given: Anne

journal_name: Human Vaccines & Immunotherapeutics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

ReferenceCitation: Dagnew AF, Rausch D, Hervé C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.

name: Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

ReferenceCitation: Colindres R, Wascotte V, Brecx A, Clarke C, Hervé C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.

name: independent Biotech and Vaccines Consultant

name: The Westmead Institute for Medical Research, University of Sydney, Sydney, Australia

ReferenceCitation: Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.

ReferenceCitation: López-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Wollongong - Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Uppsala University - Uppsala University Publications

ReferenceCitation: Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.

name: Freelance, on behalf of GSK, Wavre, Belgium

name: Health Sciences North Research Institute, Sudbury, Ontario, Canada

name: Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada

name: Diagnostics Research Group, San Antonio, Texas

name: Department of Infectious Disease, Barwon Health, Deakin University, Geelong, Victoria, Australia

name: Department of Medical Radiation Physics, Karolinska University Hospital, Stockholm, Sweden

name: Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden

name: AusTrials Pty Ltd, Sherwood, Queensland, Australia

name: School of Medicine, University of Queensland, Brisbane, Australia

name: Tampere Vaccine Research Clinic, Tampere, Finland

name: United Christian Hospital, Kowloon, Hong Kong

name: Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
Brazil
United States
Sweden
Hong Kong
Mexico
Germany
Finland
France
Czechia
Japan
Australia
Spain
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan

title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

summary:
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.


title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial

summary:
RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.

status: Unknown status

ReferenceCitation: Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Salès F, Schadendorf D, Patel P, Dummer R, Robert C, Keilholz U, Yver A, Spatz A. Ulceration and stage are predictive of interferon efficacy in melanoma: results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. Eur J Cancer. 2012 Jan;48(2):218-25. doi: 10.1016/j.ejca.2011.09.028. Epub 2011 Nov 5.

ReferenceCitation: Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up. [Abstract] J Clin Oncol 29 (Suppl 15): A-8506b, 2011.

ReferenceCitation: Bouwhuis MG, Suciu S, Testori A, Kruit WH, Salès F, Patel P, Punt CJ, Santinami M, Spatz A, Ten Hagen TL, Eggermont AM. Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991. J Clin Oncol. 2010 May 10;28(14):2460-6. doi: 10.1200/JCO.2009.24.6264. Epub 2010 Apr 12.

name: From the Department of Surgery, Division Surgical Oncology, and Department of Medical Oncology, Erasmus University Medical Center–Daniel den Hoed Cancer Center, Rotterdam; Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; Statistics Department, European Organisation for Research and Treatment of Cancer (EORTC) Headquarters; Department of Surgery, Institut Jules Bordet, Brussels, Belgium; Department of Surgery, European Institute of Oncology; Department...

family: Bouwhuis

full_name: Marna G. Bouwhuis

given: Marna G.

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: Testori

full_name: Alessandro Testori

given: Alessandro

family: Kruit

full_name: Wim H. Kruit

given: Wim H.

family: Salès

full_name: François Salès

given: François

family: Patel

full_name: Poulam Patel

given: Poulam

family: Punt

full_name: Cornelis J. Punt

given: Cornelis J.

family: Santinami

full_name: Mario Santinami

given: Mario

family: Spatz

full_name: Alain Spatz

given: Alain

family: ten Hagen

full_name: Timo L.M. ten Hagen

given: Timo L.M.

family: Eggermont

full_name: Alexander M.M. Eggermont

given: Alexander M.M.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase III Trial Comparing Adjuvant Treatment With Pegylated Interferon Alfa-2b Versus Observation: Prognostic Significance of Autoantibodies—EORTC 18991

ReferenceCitation: Eggermont AM, Bouwhuis MG, Kruit WH, Testori A, ten Hagen T, Yver A, Xu C. Serum concentrations of pegylated interferon alpha-2b in patients with resected stage III melanoma receiving adjuvant pegylated interferon alpha-2b in a randomized phase III trial (EORTC 18991). Cancer Chemother Pharmacol. 2010 Mar;65(4):671-7. doi: 10.1007/s00280-009-1072-z. Epub 2009 Jul 21.

full_name: Alexander M. M. Eggermont

given: Alexander M. M.

full_name: Timo ten Hagen

given: Timo

family: Yver

full_name: Antoine Yver

given: Antoine

family: Xu

full_name: Christine Xu

given: Christine

journal_name: Cancer Chemotherapy and Pharmacology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Serum concentrations of pegylated interferon α-2b in patients with resected stage III melanoma receiving adjuvant pegylated interferon α-2b in a randomized phase III trial (EORTC 18991)

ReferenceCitation: Bottomley A, Coens C, Suciu S, Santinami M, Kruit W, Testori A, Marsden J, Punt C, Salès F, Gore M, Mackie R, Kusic Z, Dummer R, Patel P, Schadendorf D, Spatz A, Keilholz U, Eggermont A. Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2009 Jun 20;27(18):2916-23. doi: 10.1200/JCO.2008.20.2069. Epub 2009 May 11. Erratum in: J Clin Oncol. 2009 Sep 20;27(27):4630. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

name: From the European Organisation for Research and Treatment of Cancer Quality of Life Department and Headquarters; Institut Jules Bordet, Brussels, Belgium; Istituto Nazionale dei Tumori; Istituto Europeo di Oncologia, Milan, Italy; University Hospital Birmingham, Birmingham; Royal Marsden Hospital National Health Service, London; University of Glasgow, Glasgow; Nottingham City Hospital, Nottingham, United Kingdom; Radboud University Nijmegen Medical Center, Nijmegen; Erasmus University Medical Center,...

family: Bottomley

full_name: Andrew Bottomley

title: Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group

ReferenceCitation: Fusi A, Collette S, Busse A, Suciu S, Rietz A, Santinami M, Kruit WH, Testori A, Punt CJ, Dalgleish AG, Spatz A, Eggermont AM, Keilholz U. Circulating melanoma cells and distant metastasis-free survival in stage III melanoma patients with or without adjuvant interferon treatment (EORTC 18991 side study). Eur J Cancer. 2009 Dec;45(18):3189-97. doi: 10.1016/j.ejca.2009.09.004. Epub 2009 Sep 28.

ReferenceCitation: Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, Punt CJ, Salès F, Gore M, MacKie R, Kusic Z, Dummer R, Hauschild A, Musat E, Spatz A, Keilholz U; EORTC Melanoma Group. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet. 2008 Jul 12;372(9633):117-126. doi: 10.1016/S0140-6736(08)61033-8.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991: long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to observation in resected stage III melanoma, final results of a randomized phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-8504, 473s, 2007.

location_country:
Italy
Switzerland
Netherlands
Spain
United Kingdom
Croatia
Bulgaria
France
Israel
Poland
Slovenia
Belgium
Australia
Portugal
Estonia
Germany
Czech Republic
Turkey

location_facility: Otto - Von - Guericke - Universitaet Magdeburg

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Ospendale S.M. Annunziata-A.S.DI Firenze

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Universitaet Leipzig - Chirurgische Klinik und Poliklinik I

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: North-Estonian Regional Hospital Cancer Centre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: European Institute of Oncology - Chemo Prevention

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Selly Oak Hospital at University Hospital NHS Trust

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Guy's and St. Thomas' Hospitals NHS Trust

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Centre Hospital Regional Universitaire de Limoges


type: Other Identifier

title: Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.

status: Active, not recruiting

ReferenceCitation: van der Kaaij MA, Heutte N, van Echten-Arends J, Raemaekers JM, Carde P, Noordijk EM, Fermé C, Thomas J, Eghbali H, Brice P, Bonmati C, Henry-Amar M, Kluin-Nelemans HC. Sperm quality before treatment in patients with early stage Hodgkin's lymphoma enrolled in EORTC-GELA Lymphoma Group trials. Haematologica. 2009 Dec;94(12):1691-7. doi: 10.3324/haematol.2009.009696. Epub 2009 Oct 22.

ReferenceCitation: van der Kaaij MA, Heutte N, Le Stang N, Raemaekers JM, Simons AH, Carde P, Noordijk EM, Fermé C, Thomas J, Eghbali H, Kluin-Nelemans HC, Henry-Amar M; European Organisation for Research and Treatment of Cancer: EORTC Lymphoma Group; Groupe d'Etude des Lymphomes de l'Adulte. Gonadal function in males after chemotherapy for early-stage Hodgkin's lymphoma treated in four subsequent trials by the European Organisation for Research and Treatment of Cancer: EORTC Lymphoma Group and the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2007 Jul 1;25(19):2825-32. Epub 2007 May 21.

ReferenceCitation: Eghbali H, Brice P, Creemers GY, et al.: Comparison of three radiation dose levels after EBVP regimen in favorable supradiaphragmatic clinical stages (CS) I-II Hodgkin's lymphoma (HL): preliminary results of the EORTC-GELA H9-F trial. [Abstract] Blood 106 (11): A-814, 2005.

ReferenceCitation: Ferme C, Diviné M, Vranovsky A, et al.: Four ABVD and involved-field radiotherapy in unfavorable supradiaphragmatic clinical stages (CS) I-II Hodgkin's lymphoma (HL): preliminary results of the EORTC-GELA H9-U trial. [Abstract] Blood 106 (11): A-813, 2005.

ReferenceCitation: Girinsky T, Gargi T, Carrie C, et al.: Quality assurance program in the EORTC-GELA H9 randomized study results on 282 patients. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A77, S47, 2005.

ReferenceCitation: Noordijk EM, Thomas J, Fermé C, et al.: First results of the EORTC-GELA H9 randomized trials: the H9-F trial (comparing 3 radiation dose levels) and H9-U trial (comparing 3 chemotherapy schemes) in patients with favorable or unfavorable early stage Hodgkin's lymphoma (HL) . [Abstract] J Clin Oncol 23 (Suppl 16): A-6505, 561s, 2005.

ReferenceCitation: Thomas J, Ferme C, Noordijk EM, et al.: Six cycles of EBVP followed by 36 Gy involved-field irradiation vs. no irradiation in favourable supradiaphragmatic clinical stages I-II Hodgkin's lymphoma: the EORTC-GELA strategy in 771 patients (H9-F trial-20982). [Abstract] Eur J Haematol 75 (Suppl 65): A-E11a, 40, 2004.

ReferenceCitation: Thomas J, Ferme C, Noordijk EM, et al.: Six cycles of ABVD + IF-RT vs. four cycles of ABVD + IF-RT vs. four cycles of BEACOPP + IF-RT in unfavourable supradiaphragmatic clinical stages I-II Hodgkin's lymphoma: the EORTC-GELA H9-U randomized clinical trial (20982) in 808 patients. [Abstract] Eur J Haematol 73 (Supp 65): A-E12, 40, 2004.

ReferenceCitation: Thomas J, Fermé C, Noordijk EM, Morschhauser F, Girinsky T, Gaillard I, Lugtenburg PJ, André M, Lybeert MLM, Stamatoullas A, Beijert M, Hélias P, Eghbali H, Gabarre J, van der Maazen RWM, Jaubert J, Bouabdallah K, Boulat O, Roesink JM, Christian B, Ong F, Bordessoule D, Tertian G, Gonzalez H, Vranovsky A, Quittet P, Tirelli U, de Jong D, Audouin J, Aleman BMP, Henry-Amar M. Comparison of 36 Gy, 20 Gy, or No Radiation Therapy After 6 Cycles of EBVP Chemotherapy and Complete Remission in Early-Stage Hodgkin Lymphoma Without Risk Factors: Results of the EORT-GELA H9-F Intergroup Randomized Trial. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1133-1145. doi: 10.1016/j.ijrobp.2017.10.015. Epub 2017 Oct 27.

family: Thomas

full_name: José Thomas

given: José

family: Fermé

full_name: Christophe Fermé

given: Christophe

family: Noordijk

full_name: Evert M. Noordijk

given: Evert M.

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Girinsky

full_name: Théodore Girinsky

given: Théodore

family: Gaillard

full_name: Isabelle Gaillard

given: Isabelle

family: Lugtenburg

full_name: Pieternella J. Lugtenburg

given: Pieternella J.

family: André

full_name: Marc André

given: Marc

family: Lybeert

full_name: Marnix L.M. Lybeert

given: Marnix L.M.

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

family: Beijert

full_name: Max Beijert

given: Max

family: Hélias

full_name: Philippe Hélias

given: Philippe

family: Eghbali

full_name: Houchingue Eghbali

given: Houchingue

family: Gabarre

full_name: Jean Gabarre

given: Jean

family: van der Maazen

full_name: Richard W.M. van der Maazen

given: Richard W.M.

family: Jaubert

full_name: Jérôme Jaubert

given: Jérôme

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Boulat

full_name: Olivier Boulat

given: Olivier

family: Roesink

full_name: Judith M. Roesink

given: Judith M.

family: Christian

full_name: Bernard Christian

given: Bernard

family: Ong

full_name: Francisca Ong

given: Francisca

journal_name: International Journal of Radiation Oncology*Biology*Physics

ReferenceCitation: Fermé C, Thomas J, Brice P, Casasnovas O, Vranovsky A, Bologna S, Lugtenburg PJ, Bouabdallah R, Carde P, Sebban C, Eghbali H, Salles G, van Imhoff GW, Thyss A, Noordijk EM, Reman O, Lybeert MLM, Janvier M, Spina M, Audhuy B, Raemaekers JMM, Delarue R, Anglaret B, de Weerdt O, Marjanovic Z, Tersteeg RJHA, de Jong D, Brière J, Henry-Amar M; European Organisation for Research and Treatment of Cancer Lymphoma Group, and; Groupe d'Étude des Lymphomes de l'Adulte. ABVD or BEACOPP(baseline) along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors: Results of the European Organisation for Research and Treatment of Cancer (EORTC)-Groupe d'Étude des Lymphomes de l'Adulte (GELA) H9-U intergroup randomised trial. Eur J Cancer. 2017 Aug;81:45-55. doi: 10.1016/j.ejca.2017.05.005. Epub 2017 Jun 8.

title: ABVD or BEACOPP baseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors: Results of the European Organisation for Research and Treatment of Cancer (EORTC)–Groupe d'Étude des Lymphomes de l'Adulte (GELA) H9-U intergroup randomised trial

location_country: Italy Switzerland Netherlands Spain Poland France Slovakia Belgium Portugal Slovenia

location_facility: Centre Hospital General Robert Ballanger

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Turin

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Hopital de la Croix Rouge Francaise des Peupliers

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Centre d'Oncologie et de Radiotherapie de Chaumont le Bois


ReferenceCitation: Coleman R, Finkelstein DM, Barrios C, Martin M, Iwata H, Hegg R, Glaspy J, Periañez AM, Tonkin K, Deleu I, Sohn J, Crown J, Delaloge S, Dai T, Zhou Y, Jandial D, Chan A. Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):60-72. doi: 10.1016/S1470-2045(19)30687-4. Epub 2019 Dec 2.

ReferenceCitation: Coleman R, Zhou Y, Jandial D, Cadieux B, Chan A. Bone Health Outcomes from the International, Multicenter, Randomized, Phase 3, Placebo-Controlled D-CARE Study Assessing Adjuvant Denosumab in Early Breast Cancer. Adv Ther. 2021 Aug;38(8):4569-4580. doi: 10.1007/s12325-021-01812-9. Epub 2021 Jun 29.

status: Terminated

lead_sponsor: Amgen

location_country:
Peru
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey
Latvia

type: EudraCT Number

source: euctr

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

summary: This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.


ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
Romania
Belgium
Russian Federation
France
Poland
Argentina
Canada
Colombia
South Africa
Sweden
Switzerland
Hungary
Ireland
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Belarus
Spain

acronym: DIAMOND

ipd_sharing: Yes

title: A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)

summary: Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.


title: Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

ReferenceCitation: Fensterer H, Radlwimmer B, Sträter J, Buchholz M, Aust DE, Julié C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Köhne CH, Kestler HA, Schwaenen C, Nessling M, Lutz MP, Lichter P, Gress TM; EORTC Gastrointestinal (GI) Group. Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer. 2007 Apr 2;7:58.

ReferenceCitation: Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.

lead_sponsor: Robert Roessle Klinik

location_country: Serbia Netherlands France Belgium Spain Germany

location_facility: Hospital Universitari Sant Joan d'Alacant

location_facility: Centre Hospitalier de Chalons - en - Champagne

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Hospital General Universitario De Guadalajara

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: Centre Hospitalier General - St. Nicolas

intervention_type: Procedure


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)

acronym: Mainsail

summary:
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

ReferenceCitation: Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.

ReferenceCitation: Petrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.

family: Petrylak

full_name: Daniel P Petrylak

given: Daniel P

family: Vogelzang

full_name: Nicholas J Vogelzang

given: Nicholas J

family: Budnik

full_name: Nikolay Budnik

given: Nikolay

family: Wiechno

full_name: Pawel Jan Wiechno

given: Pawel Jan

family: Sternberg

full_name: Cora N Sternberg

given: Cora N

family: Doner

full_name: Kevin Doner

given: Kevin

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Burke

full_name: John M Burke

given: John M

family: de Olza

full_name: Maria Ochoa de Olza

given: Maria Ochoa

family: Choudhury

full_name: Ananya Choudhury

given: Ananya

family: Gschwend

full_name: Juergen E Gschwend

given: Juergen E

family: Kopyltsov

full_name: Evgeny Kopyltsov

given: Evgeny

family: Flechon

full_name: Aude Flechon

given: Aude

family: Van As

full_name: Nicolas Van As

given: Nicolas

family: Houede

full_name: Nadine Houede

given: Nadine

family: Barton

full_name: Debora Barton

given: Debora

family: Fandi

full_name: Abderrahim Fandi

given: Abderrahim

family: Jungnelius

full_name: Ulf Jungnelius

given: Ulf

family: Li

full_name: Shaoyi Li

given: Shaoyi

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Fizazi

full_name: Karim Fizazi

given: Karim

journal_name: The Lancet Oncology

publisher: Elsevier BV

ReferenceCitation: de Morrée ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.

name: Erasmus MC Cancer Institute, Department of Medical Oncology, Rotterdam, the Netherlands

name: US Oncology Research, Houston, Texas3Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada

name: Yale Cancer Center, Division of Oncology, Department of Medicine, New Haven, Connecticut

name: NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways, Rostov-on-Don, Russia

name: Department of Uro-Oncology, Centrum Onkologii – Instytut im. Marii Sklodowskiej-Curie, Warsaw, Poland

name: San Camillo and Forlanini Hospitals, Department of Medical Oncology, Rome, Italy

name: University Hospital del Mar-IMIM, Barcelona, Spain10Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts

name: US Oncology Research, Houston, Texas11Rocky Mountain Cancer Centers, Aurora, Colorado

name: Catalan Institute of Oncology, Department of Medical Oncology, Barcelona, Spain

name: Department of Clinical Oncology, The Christie NHS Foundation Trust and Institute of Cancer Sciences, University of Manchester, Manchester, England

name: Department of Urology, Rechts der Isar Medical Center, Technische Universität München, München, Germany

name: State Institution of Healthcare “ Regional Clinical Oncology Dispensary”, Omsk, Russia

name: Centre Léon Bérard, Department of Medical Oncology, Lyon, France

name: Department of Clinical Oncology, Royal Marsden Hospital, London, England

name: Medical Oncology Department, Groupe Hospitalier Universitaire Caremeau Place du Professeur Robert Debré, Nîmes, France

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
France
Poland
Canada
South Africa
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

location_facility: Northern Lincolnshire and Goole Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Miserico

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.

location_facility: Hematology-Oncology Associates of NNJ, P

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hematology Oncology Associates of South Jersey

location_facility: Weill Cornell Medical College Dr. Feldman's Office

location_facility: Consultorio Privado- Dr Jose Arturo Rodriguez Rivera

location_facility: Veterans Education and Research Association of Northern New England, Inc.

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: IORC- Innovation Onkologie Research and Consulting GmbH

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Regionalny Osrodek Onkologiczny WSS im. M. Kopernika

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Texas Oncology Deke Slayton Cancer Center

location_facility: Summit Medical Group Overlook Oncology Center

location_facility: ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii

location_facility: Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Albert Schweitzer Ziekenhuis Amstelwijck

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Netcare Oncology and Interventional Centre

location_facility: Oncology Dispensary 2 of Krasnodar Region

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

location_facility: Rocky Mountain Cancer Centers-Colorado Springs Circle

location_facility: Praxis fuer Haematologie und Onkologie Koblenz

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: The Health Institute for Men CMX Research Inc

location_facility: Scripps Cancer Center - Clinical Research

location_facility: NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o

location_facility: The Angeles Clinc and Research Institute

location_facility: Fairfax Northern Virginia Hematology Oncology

location_facility: Cancer Centers of Florida, P.A.- West Gore Street

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

location_facility: State Institution of Heath Omsk Regional Oncology Dispensary

location_facility: Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO

location_facility: Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.

location_facility: Northern AZ Hematology and Oncology Assoc

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

location_facility: Chattanooga Oncology Hematology Associates


title: A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.

enrollment_type: Anticipated

ReferenceCitation: Reiman T, Lai R, Veillard AS, Paris E, Soria JC, Rosell R, Taron M, Graziano S, Kratzke R, Seymour L, Shepherd FA, Pignon JP, Sève P. Cross-validation study of class III beta-tubulin as a predictive marker for benefit from adjuvant chemotherapy in resected non-small-cell lung cancer: analysis of four randomized trials. Ann Oncol. 2012 Jan;23(1):86-93. doi: 10.1093/annonc/mdr033. Epub 2011 Apr 6.

ReferenceCitation: Hotta K, Matsuo K, Kiura K, Ueoka H, Tanimoto M. Advances in our understanding of postoperative adjuvant chemotherapy in resectable non-small-cell lung cancer. Curr Opin Oncol. 2006 Mar;18(2):144-50. Review.

ReferenceCitation: Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.

ReferenceCitation: Wakelee HA, Schiller JH, Gandara DR. Current status of adjuvant chemotherapy for stage IB non-small-cell lung cancer: implications for the New Intergroup Trial. Clin Lung Cancer. 2006 Jul;8(1):18-21. Review.

ReferenceCitation: Bepler G, Olaussen KA, Vataire AL, Soria JC, Zheng Z, Dunant A, Pignon JP, Schell MJ, Fouret P, Pirker R, Filipits M, Brambilla E. ERCC1 and RRM1 in the international adjuvant lung trial by automated quantitative in situ analysis. Am J Pathol. 2011 Jan;178(1):69-78. doi: 10.1016/j.ajpath.2010.11.029. Epub 2010 Dec 23.

family: Bepler

full_name: Gerold Bepler

given: Gerold

family: Olaussen

full_name: Ken André Olaussen

given: Ken André

family: Vataire

full_name: Anne-Lise Vataire

given: Anne-Lise

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Zheng

full_name: Zhong Zheng

given: Zhong

family: Dunant

full_name: Ariane Dunant

given: Ariane

family: Pignon

full_name: Jean-Pierre Pignon

given: Jean-Pierre

family: Schell

full_name: Michael J. Schell

given: Michael J.

family: Fouret

full_name: Pierre Fouret

given: Pierre

family: Pirker

full_name: Robert Pirker

given: Robert

family: Filipits

full_name: Martin Filipits

given: Martin

family: Brambilla

full_name: Elisabeth Brambilla

given: Elisabeth

journal_name: The American Journal of Pathology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: ERCC1 and RRM1 in the International Adjuvant Lung Trial by Automated Quantitative in Situ Analysis

ReferenceCitation: Arriagada R, Dunant A, Pignon JP, Bergman B, Chabowski M, Grunenwald D, Kozlowski M, Le Péchoux C, Pirker R, Pinel MI, Tarayre M, Le Chevalier T. Long-term results of the international adjuvant lung cancer trial evaluating adjuvant Cisplatin-based chemotherapy in resected lung cancer. J Clin Oncol. 2010 Jan 1;28(1):35-42. doi: 10.1200/JCO.2009.23.2272. Epub 2009 Nov 23.

name: From the Institut Gustave-Roussy, Villejuif; University of Paris-Sud; Hôpital Tenon, Paris, France; Karolinska Institutet, Stockholm; Sahlgrenska University Hospital, Gothenburg, Sweden; Lung Diseases Research Institute, Warsaw; Medical University of Bialystok, Bialystok, Poland; Medical University of Vienna, Austria; and Instituto Nacional de Câncer, Rio de Janeiro, Brazil.

family: Arriagada

full_name: Rodrigo Arriagada

given: Rodrigo

family: Bergman

full_name: Bengt Bergman

publisher_group: American Society of Clinical Oncology (ASCO)

title: Long-Term Results of the International Adjuvant Lung Cancer Trial Evaluating Adjuvant Cisplatin-Based Chemotherapy in Resected Lung Cancer

ReferenceCitation: Voortman J, Goto A, Mendiboure J, Sohn JJ, Schetter AJ, Saito M, Dunant A, Pham TC, Petrini I, Lee A, Khan MA, Hainaut P, Pignon JP, Brambilla E, Popper HH, Filipits M, Harris CC, Giaccone G. MicroRNA expression and clinical outcomes in patients treated with adjuvant chemotherapy after complete resection of non-small cell lung carcinoma. Cancer Res. 2010 Nov 1;70(21):8288-98. doi: 10.1158/0008-5472.CAN-10-1348. Epub 2010 Oct 26.

publisher: American Association for Cancer Research (AACR)

title: MicroRNA Expression and Clinical Outcomes in Patients Treated with Adjuvant Chemotherapy after Complete Resection of Non–Small Cell Lung Carcinoma

ReferenceCitation: Filipits M, Pirker R, Dunant A, Lantuejoul S, Schmid K, Huynh A, Haddad V, André F, Stahel R, Pignon JP, Soria JC, Popper HH, Le Chevalier T, Brambilla E. Cell cycle regulators and outcome of adjuvant cisplatin-based chemotherapy in completely resected non-small-cell lung cancer: the International Adjuvant Lung Cancer Trial Biologic Program. J Clin Oncol. 2007 Jul 1;25(19):2735-40.

ReferenceCitation: Olaussen KA, Dunant A, Fouret P, Brambilla E, André F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91.

ReferenceCitation: Brambilla E, Dunant A, Filipits M, et al.: Prognostic and predictive role of alterations of the P53-bax-bcl2 pathway of apoptosis in the IALT (International Adjuvant Lung Cancer Trial). [Abstract] Lung Cancer 50 (Suppl 2): A-O-021, S10, 2005.

ReferenceCitation: Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60.

ReferenceCitation: Le Chevalier T: Results of the Randomized International Adjuvant Lung Cancer Trial (IALT): cisplatin-based chemotherapy (CT) vs no CT in 1867 patients (pts) with resected non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-6, 2, 2003.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Centre Hospital General Robert Ballanger

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Department of Children Hematology/Oncology University of Medicine Wroclaw

location_facility: Athens University-Laikon General Hospital

location_facility: Chest Disease Clinic, Charles University

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Comprehensive Cancer Center at JFK Medical Center

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Centre de Radiologie et de Traitement des Tumeurs

location_facility: South Eastern Sydney Area Health Service


title: POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL

summary:
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma.

ReferenceCitation: Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Salès F, Schadendorf D, Patel P, Dummer R, Robert C, Keilholz U, Yver A, Spatz A. Ulceration and stage are predictive of interferon efficacy in melanoma: results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. Eur J Cancer. 2012 Jan;48(2):218-25. doi: 10.1016/j.ejca.2011.09.028. Epub 2011 Nov 5.

ReferenceCitation: Bouwhuis MG, Suciu S, Collette S, Aamdal S, Kruit WH, Bastholt L, Stierner U, Salès F, Patel P, Punt CJ, Hernberg M, Spatz A, ten Hagen TL, Hansson J, Eggermont AM; EORTC Melanoma Group and the Nordic Melanoma Group. Autoimmune antibodies and recurrence-free interval in melanoma patients treated with adjuvant interferon. J Natl Cancer Inst. 2009 Jun 16;101(12):869-77. doi: 10.1093/jnci/djp132. Epub 2009 Jun 9.

ReferenceCitation: Eggermont AM, Punt CJ. Does adjuvant systemic therapy with interferon-alpha for stage II-III melanoma prolong survival? Am J Clin Dermatol. 2003;4(8):531-6. Review.

ReferenceCitation: Bouwhuis MG, Collette S, Suciu S, de Groot ER, Kruit WH, Ten Hagen TL, Aarden LA, Eggermont AM, Swaak AJ; EORTC Melanoma Group. Changes of ferritin and CRP levels in melanoma patients treated with adjuvant interferon-α (EORTC 18952) and prognostic value on treatment outcome. Melanoma Res. 2011 Aug;21(4):344-51. doi: 10.1097/CMR.0b013e328346c17f.

family: Bouwhuis

full_name: Marna G. Bouwhuis

given: Marna G.

family: Collette

full_name: Sandra Collette

given: Sandra

family: Suciu

full_name: Stefan Suciu

given: Stefan

family: de Groot

full_name: Els R. de Groot

given: Els R.

family: Kruit

full_name: Wim H. Kruit

given: Wim H.

family: ten Hagen

full_name: Timo L.M. ten Hagen

given: Timo L.M.

family: Aarden

full_name: Lucien A. Aarden

given: Lucien A.

family: Eggermont

full_name: Alexander M.M. Eggermont

given: Alexander M.M.

family: Swaak

full_name: Antonius J.G. Swaak

given: Antonius J.G.

journal_name: Melanoma Research

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Changes of ferritin and CRP levels in melanoma patients treated with adjuvant interferon-α (EORTC 18 952) and prognostic value on treatment outcome

ReferenceCitation: Bouwhuis MG, Suciu S, Kruit W, Salès F, Stoitchkov K, Patel P, Cocquyt V, Thomas J, Liénard D, Eggermont AM, Ghanem G; European Organisation for Research and Treatment of Cancer Melanoma Group. Prognostic value of serial blood S100B determinations in stage IIB-III melanoma patients: a corollary study to EORTC trial 18952. Eur J Cancer. 2011 Feb;47(3):361-8. doi: 10.1016/j.ejca.2010.10.005. Epub 2010 Nov 17.

full_name: M.G. Bouwhuis

full_name: S. Suciu

given: S.

full_name: W. Kruit

given: W.

family: Salès

full_name: F. Salès

given: F.

family: Stoitchkov

full_name: K. Stoitchkov

given: K.

family: Patel

full_name: P. Patel

given: P.

family: Cocquyt

full_name: V. Cocquyt

given: V.

family: Thomas

full_name: J. Thomas

given: J.

family: Liénard

full_name: D. Liénard

given: D.

full_name: A.M.M. Eggermont

family: Ghanem

full_name: G. Ghanem

given: G.

title: Prognostic value of serial blood S100B determinations in stage IIB–III melanoma patients: A corollary study to EORTC trial 18952

ReferenceCitation: Bouwhuis M, Suciu S, Kruit W, et al.: Prognostic value of autoantibodies (auto-AB) in melanoma patients (pts) in the EORTC 18952 trial of adjuvant interferon (IFN) compared to observation (obs). [Abstract] J Clin Oncol 25 (Suppl 18): A-8507, 473s, 2007.

ReferenceCitation: Suciu S, Ghanem G, Kruit W, et al.: Serum S-100B protein is a strong independent prognostic marker for distant-metastasis free survival (DMFS) in stage III melanoma patients: an evaluation of the EORTC randomized trial 18952 comparing IFNα versus observation. [Abstract] J Clin Oncol 25 (Suppl 18): A-8518, 476s, 2007.

ReferenceCitation: Eggermont AM, Suciu S, MacKie R, Ruka W, Testori A, Kruit W, Punt CJ, Delauney M, Sales F, Groenewegen G, Ruiter DJ, Jagiello I, Stoitchkov K, Keilholz U, Lienard D; EORTC Melanoma Group. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet. 2005 Oct 1;366(9492):1189-96.

location_country:
Finland
Belgium
Russian Federation
Croatia
France
Poland
Slovakia
Turkey
Sweden
Switzerland
Netherlands
Bulgaria
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Israel
Spain
Estonia

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Department of Dematology, Hannover Medical School

location_facility: Maria Sklodowska-Curie M.C.C.I.O. Krakow

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Istanbul University-Institute of Oncology

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Tel-Aviv Medical Center-Ichilov Hospital

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Universitatshautklinik Eberhard - Karlsuniversitat Tubingen


title: Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia

acronym: PROMOTE-ALI

summary: The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Behrendt CA, Björck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22.

ReferenceCitation: Björck M, Earnshaw JJ, Acosta S, Bastos Gonçalves F, Cochennec F, Debus ES, Hinchliffe R, Jongkind V, Koelemay MJW, Menyhei G, Svetlikov AV, Tshomba Y, Van Den Berg JC, Esvs Guidelines Committee, de Borst GJ, Chakfé N, Kakkos SK, Koncar I, Lindholt JS, Tulamo R, Vega de Ceniga M, Vermassen F, Document Reviewers, Boyle JR, Mani K, Azuma N, Choke ETC, Cohnert TU, Fitridge RA, Forbes TL, Hamady MS, Munoz A, Müller-Hülsbeck S, Rai K. Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia. Eur J Vasc Endovasc Surg. 2020 Feb;59(2):173-218. doi: 10.1016/j.ejvs.2019.09.006. Epub 2019 Dec 31.

ipd_sharing: No

lead_sponsor: Medical University Innsbruck

location_country:
Italy
Austria
Serbia
Switzerland
Netherlands
Spain
France
Norway
Portugal
Denmark
Germany
United Kingdom

location_facility: Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins

location_facility: Department of Angiology and Vascular Surgery, Hospital de S. João

location_facility: Department of Surgery, Medical Faculty Mannheim

location_facility: Department of Angiology and Vascular Surgery, Hospital Vall D'Hebron

location_facility: Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University

location_facility: Department of Vascular and Endovascular Surgery, University Hospital of Besançon

location_facility: Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia

location_facility: Department of Angiology and Vascular Surgery, Hospital Virgen de la Luz

location_facility: Department of Vascular Surgery, Ludwig-Maximilians University Hospital

location_facility: Department of Angiology and Vascular Surgery, Hospital Clínico Universitario de Valladolid

location_facility: Department of Vascular Surgery, Bordeaux University Hospital

location_facility: Institute for Cardiovascular Disease, Belgrade

location_facility: Medical University of Innsbruck, Department of Vascular Surgery

location_facility: Dijklander hospital, Department of Surgery

location_facility: Clinic for Vascular and Endovascular Surgery, Medical Faculty, University Augsburg

location_facility: Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna

location_facility: Department of Vascular and Endovascular Surgery, Hospital Ottakring

location_facility: Department of Vascular Surgery, Medical University Graz

location_facility: European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University

location_facility: University Medical Center Utrecht, Department of Vascular Surgery

location_facility: Department of Vascular Surgery, CHU de Reims

location_facility: Department of Vascular and Endovascular Surgery, University Hospital Münster

location_facility: Department of Vascular Surgery, University Hospital of Nancy

location_facility: Department of Cardiothoracic and Vascular Surgery, University of Ulm

location_facility: Department of Vascular Surgery, LKH Feldkirch

location_facility: Department of Angiology and Vascular Surgery, Hospital Universitario 12 de Octubre

location_facility: Department of Vascular and Endovascular Surgery, Santa Marta Hospital, Centro Hospitalar Lisboa Central

location_facility: CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire

location_facility: Department of Vascular Surgery, University Hospital of Dijon

location_facility: Department of Vascular Surgery, Henri Mondor University Hospital

location_facility: Department of Vascular Surgery, Ambroise Paré University Hospital, Boulogne-Billancourt and Simone Veil Health Sciences Medical School, Versailles-Saint-Quentin-en-Yvelines University and Paris-Saclay University

location_facility: Vascular Surgery Department, Algarve University Medical Centre

location_facility: Department of Vascular Surgery, University Hospital Wales

location_facility: Department of Angiology and Vascular Surgery, Hospital Miguel Servet

location_facility: Department of Vascular and Endovascular Surgery, Brest University Hospital

location_facility: Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg

location_facility: Department of Vascular Surgery, Kantonsspital Winterthur

location_facility: Department of Angiology and Vascular Surgery, Hospital General Universitario de Toledo

location_facility: Department of Vascular Surgery, Countess of Chester Hospital

location_facility: University Hospital of Nice, Université Côte d'Azur

location_facility: Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf

location_facility: Department of Vascular and Endovascular Surgery, Haukeland University Hospital

location_facility: Clinic for Vascular Surgery, Clinical Center Niš

location_facility: Vascular Surgery Department, Hospices Civils de Lyon

location_facility: Department of Vascular Surgery, University Hospital of Nice

location_facility: Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris

location_facility: Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research

location_facility: Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna

location_facility: Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol

location_facility: Department of Cardiovascular Surgery, Inselspital, University of Bern

location_facility: Division of Vascular and Endovascular Surgery Department for Visceral-, Thoracic and Vascular Surgery Medical Faculty Carl Gustav Carus and University Hospital Carl Gustav Carus Dresden Technische Universität Dresden

location_facility: Amsterdam University Medical Center, Department of Surgery

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients

acronym: PSO-TARGET

summary:
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.

The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.

status: Recruiting

lead_sponsor: Clinact

location_country: Belgium France

location_facility: Cliniques Universitaires Saint Luc - UCLouvain

location_facility: Hôpital d'Instruction des armées SAINTE ANNE


title: A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

summary: This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Saudi Arabia
Netherlands
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain