title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer

acronym: REDUCE

summary: This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

ReferenceCitation: Kader AK, Sun J, Reck BH, Newcombe PJ, Kim ST, Hsu FC, D'Agostino RB Jr, Tao S, Zhang Z, Turner AR, Platek GT, Spraggs CF, Whittaker JC, Lane BR, Isaacs WB, Meyers DA, Bleecker ER, Torti FM, Trent JM, McConnell JD, Zheng SL, Condreay LD, Rittmaster RS, Xu J. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol. 2012 Dec;62(6):953-61. doi: 10.1016/j.eururo.2012.05.006. Epub 2012 May 12.

ReferenceCitation: Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster R, Andriole GL, Groskopf J. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17.

ReferenceCitation: Wu C, Moreira DM, Gerber L, Rittmaster RS, Andriole GL, Freedland SJ. Diabetes and prostate cancer risk in the REDUCE trial. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):326-31. doi: 10.1038/pcan.2011.28. Epub 2011 Jun 28.

ReferenceCitation: Roehrborn CG, Nickel JC, Andriole GL, Gagnier RP, Black L, Wilson TH, Rittmaster RS. Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011 Sep;78(3):641-6. doi: 10.1016/j.urology.2011.03.063. Epub 2011 Jul 20.

ReferenceCitation: Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster RS. Prostate needle biopsy quality in reduction by dutasteride of prostate cancer events study: worldwide comparison of improvement with investigator training and centralized laboratory processing. Urology. 2010 Jun;75(6):1406-10. doi: 10.1016/j.urology.2009.07.1348. Epub 2009 Nov 25.

ReferenceCitation: Crawford ED, Andriole GL, Marberger M, Rittmaster RS. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial. Urology. 2010 Mar;75(3):502-9. doi: 10.1016/j.urology.2009.05.099. Epub 2009 Dec 29. Review.

ReferenceCitation: Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127.

ReferenceCitation: Andriole GL, Bostwick D, Brawley OW, Gomella L, Marberger M, Montorsi F, Pettaway C, Tammela TL, Teloken C, Tindall D, Freedland SJ, Somerville MC, Wilson TH, Fowler I, Castro R, Rittmaster RS; REDUCE Study Group. The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: results from the REDUCE study. J Urol. 2011 Jan;185(1):126-31. doi: 10.1016/j.juro.2010.09.011. Epub 2010 Nov 12.

ReferenceCitation: Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS. Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. J Urol. 2011 Oct;186(4):1313-8. doi: 10.1016/j.juro.2011.05.071. Epub 2011 Aug 17.

ReferenceCitation: Thomas JA 2nd, Gerber L, Moreira DM, Hamilton RJ, Bañez LL, Castro-Santamaria R, Andriole GL, Isaacs WB, Xu J, Freedland SJ. Prostate cancer risk in men with prostate and breast cancer family history: results from the REDUCE study (R1). J Intern Med. 2012 Jul;272(1):85-92. doi: 10.1111/j.1365-2796.2011.02504.x. Epub 2012 Jan 16.

ReferenceCitation: Marberger M, McConnell JD, Fowler I, Andriole GL, Bostwick DG, Somerville MC, Rittmaster RS. Biopsy misidentification identified by DNA profiling in a large multicenter trial. J Clin Oncol. 2011 May 1;29(13):1744-9. doi: 10.1200/JCO.2010.32.1646. Epub 2011 Mar 28.

ReferenceCitation: Marberger M, Freedland SJ, Andriole GL, Emberton M, Pettaway C, Montorsi F, Teloken C, Rittmaster RS, Somerville MC, Castro R. Usefulness of prostate-specific antigen (PSA) rise as a marker of prostate cancer in men treated with dutasteride: lessons from the REDUCE study. BJU Int. 2012 Apr;109(8):1162-9. doi: 10.1111/j.1464-410X.2011.10373.x. Epub 2011 Jun 23.

ReferenceCitation: Marberger M, Wilson TH, Rittmaster RS. Low serum testosterone levels are poor predictors of sexual dysfunction. BJU Int. 2011 Jul;108(2):256-62. doi: 10.1111/j.1464-410X.2010.09766.x. Epub 2010 Oct 18.

ReferenceCitation: Kattan MW, Earnshaw SR, McDade CL, Black LK, Andriole GL. Cost effectiveness of chemoprevention for prostate cancer with dutasteride in a high-risk population based on results from the REDUCE clinical trial. Appl Health Econ Health Policy. 2011 Sep 1;9(5):305-15. doi: 10.2165/11592200-000000000-00000.

ReferenceCitation: Muller RL, Gerber L, Moreira DM, Andriole G, Castro-Santamaria R, Freedland SJ. Serum testosterone and dihydrotestosterone and prostate cancer risk in the placebo arm of the Reduction by Dutasteride of Prostate Cancer Events trial. Eur Urol. 2012 Nov;62(5):757-64. doi: 10.1016/j.eururo.2012.05.025. Epub 2012 May 18.

ReferenceCitation: Newcombe PJ, Reck BH, Sun J, Platek GT, Verzilli C, Kader AK, Kim ST, Hsu FC, Zhang Z, Zheng SL, Mooser VE, Condreay LD, Spraggs CF, Whittaker JC, Rittmaster RS, Xu J. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. Genet Epidemiol. 2012 Jan;36(1):71-83. doi: 10.1002/gepi.21600.

ReferenceCitation: Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster RS, Andriole GL, Groskopf J. Prostate cancer gene 3 score predicts prostate biopsy outcome in men receiving dutasteride for prevention of prostate cancer: results from the REDUCE trial. Urology. 2011 Aug;78(2):380-5. doi: 10.1016/j.urology.2011.03.033.

ReferenceCitation: Stephen J. Freedland, Leah Gerber, Lionel Banez, Daniel Moreira, Gerald L. Andriole, and Roger S. Rittmaster on behalf of the REDUCE Study Group. Statin Use and the Risk of Prostate Cancer and High-grade Prostate Cancer: Results from the REDUCE study. [AUA 2011 Annual Meeting]. 2011;185(4 Suppl):e135.

ReferenceCitation: Thomas JA 2nd, Gerber L, Bañez LL, Moreira DM, Rittmaster RS, Andriole GL, Freedland SJ. Prostate cancer risk in men with baseline history of coronary artery disease: results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2012 Apr;21(4):576-81. doi: 10.1158/1055-9965.EPI-11-1017. Epub 2012 Feb 7.

ReferenceCitation: Vidal AC, Oyekunle T, Feng T, Freedland AR, Moreira D, Castro-Santamaria R, Andriole GL, Freedland SJ, Allott EH. Asian Race and Risk of Prostate Cancer: Results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2020 Nov;29(11):2165-2170. doi: 10.1158/1055-9965.EPI-20-0646. Epub 2020 Aug 20.

ReferenceCitation: Bliwise DL, Howard LE, Moreira DM, Andriole GL, Hopp ML, Freedland SJ. Nocturia and associated mortality: observational data from the REDUCE trial. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):77-83. doi: 10.1038/s41391-018-0090-5. Epub 2018 Sep 13.

ReferenceCitation: Moreira DM, Andriole GL, Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ. Dutasteride is associated with reduced risk of transrectal prostate biopsy-associated urinary tract infection and related hospitalizations. World J Urol. 2017 Oct;35(10):1525-1530. doi: 10.1007/s00345-017-2036-2. Epub 2017 Apr 10.

ReferenceCitation: Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ, Moreira DM. Chronic Prostate Inflammation is Associated with Severity and Progression of Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Risk of Acute Urinary Retention. J Urol. 2016 Nov;196(5):1493-1498. doi: 10.1016/j.juro.2016.06.090. Epub 2016 Jul 1.

ReferenceCitation: Moreira DM, Nickel JC, Andriole GL, Castro-Santamaria R, Freedland SJ. Chronic baseline prostate inflammation is associated with lower tumor volume in men with prostate cancer on repeat biopsy: Results from the REDUCE study. Prostate. 2015 Sep;75(13):1492-8. doi: 10.1002/pros.23041. Epub 2015 Jul 17.

ReferenceCitation: Moreira DM, Bostwick DG, Andriole GL, Peterson BL, Cohen HJ, Castro-Santamaria R, Freedland SJ. Baseline Prostate Atrophy is Associated with Reduced Risk of Prostate Cancer in Men Undergoing Repeat Prostate Biopsy. J Urol. 2015 Nov;194(5):1241-6. doi: 10.1016/j.juro.2015.05.103. Epub 2015 Jul 10.

ReferenceCitation: Toren P, Margel D, Kulkarni G, Finelli A, Zlotta A, Fleshner N. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ. 2013 Apr 15;346:f2109. doi: 10.1136/bmj.f2109.

ReferenceCitation: Muller RL, Gerber L, Moreira DM, Andriole G Jr, Hamilton RJ, Fleshner N, Parsons JK, Freedland SJ. Obesity is associated with increased prostate growth and attenuated prostate volume reduction by dutasteride. Eur Urol. 2013 Jun;63(6):1115-21. doi: 10.1016/j.eururo.2013.02.038. Epub 2013 Mar 7.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Tunisia
Puerto Rico
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Belarus
Greece
Ireland
Estonia
Latvia
Finland
New Zealand
France
Chile
Netherlands


type: Other Identifier

type: EudraCT Number

title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.

study_start_date_type: Actual

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score ≥ 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25.

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

location_country:
Croatia
Poland
Spain
United Kingdom
Australia
New Zealand
Canada
Sweden
Hungary
France
Belgium
Netherlands
Czechia

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Karolinska University Hospital - Huddinge

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Edmond Odette Cancer Centre at Sunnybrook

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

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: McGill Cancer Centre at McGill University

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Saskatoon Cancer Centre at the University of Saskatchewan

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Nepean Cancer Care Centre at Nepean Hospital

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

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


summary: Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.

status: Completed

lead_sponsor: Eli Lilly and Company

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Romania
Belgium
South Africa
Austria
Australia
Russian Federation
India
Mexico
Norway
Singapore
Sweden
Slovakia
Egypt
Brazil
Lebanon
Canada
Switzerland
Germany
Denmark
Taiwan
New Zealand
Finland
Czech Republic
Thailand
France
Chile
Netherlands

location_facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.

location_facility: timoreFor additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

intervention_type: Drug

status_simplified: Completed


title: Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

acronym: IES

summary: To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.

study_completion_date_type: Actual

lead_sponsor: Pfizer

location_country:
Croatia
Luxembourg
Serbia
Italy
Spain
United Kingdom
United States
Peru
Belgium
Romania
South Africa
Poland
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
Argentina
Israel
Malta
Norway
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
New Zealand
Czech Republic
France
Netherlands


title: Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

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 combination chemotherapy regimen is more effective for urinary tract cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

ReferenceType: result

ReferenceCitation: Bellmunt J, von der Maase H, Mead GM, Skoneczna I, De Santis M, Daugaard G, Boehle A, Chevreau C, Paz-Ares L, Laufman LR, Winquist E, Raghavan D, Marreaud S, Collette S, Sylvester R, de Wit R. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012 Apr 1;30(10):1107-13. doi: 10.1200/JCO.2011.38.6979. Epub 2012 Feb 27. Erratum in: J Clin Oncol. 2018 Mar 10;36(8):833.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Hungary
United States
France
Israel
Belgium
Germany
Slovakia

location_facility: Veterans Affairs Medical Center - San Antonio (Murphy)

location_facility: Veterans Affairs Medical Center - Tucson

location_facility: Providence Cancer Institute at Providence Hospital

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Josephine Ford Cancer Center at Henry Ford Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

location_facility: Krankenhaus Hohe Warte Mediziniche Klinik

location_facility: Prostate Centre at Vancouver General Hospital

location_facility: Veterans Affairs Medical Center - Ann Arbor

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Veterans Affairs Medical Center - Portland

location_facility: Veterans Affairs Medical Center - Kansas City

location_facility: Cancer Institute at Oregon Health and Science University

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Hospital General Universitario De Guadalajara

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: City of Hope Comprehensive Cancer Center

location_facility: St. Mary's - Duluth Clinic Cancer Center

location_facility: Algoma Reginal Cancer Program at Sault Area Hospital

location_facility: Charles M. Barrett Cancer Center at University Hospital

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

location_facility: Veterans Affairs Medical Center - Lexington

location_facility: James P. Wilmot Cancer Center at University of Rochester Medical Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Klinik und Poliklinik fuer Kinderheilkunde

location_facility: Veterans Affairs Medical Center - Seattle

location_facility: Veterans Affairs Medical Center - Shreveport

location_facility: Jonsson Comprehensive Cancer Center, UCLA

location_facility: Arizona Cancer Center at University of Arizona Health Sciences Center

location_facility: Veterans Affairs Medical Center - New Orleans

location_facility: Centre Hospitalier Regional de Lanaudiere

location_facility: Veterans Affairs Medical Center - Oklahoma City

location_facility: Northeastern Ontario Regional Cancer Centre - Sudbury

location_facility: Durham Regional Cancer Centre at Lakeridge Health Oshawa

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Markey Cancer Center at University of Kentucky Chandler Medical Center

location_facility: Veterans Affairs Medical Center - Charleston

location_facility: Veterans Affairs Medical Center - Amarillo

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Velindre Cancer Center at Velinde Hospital

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Cancer Research Center at Boston Medical Center

location_facility: Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

location_facility: Hollings Cancer Center at Medical University of South Carolina

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

location_facility: St. Louis University Hospital Cancer Center

location_facility: Herbert Irving Comprehensive Cancer Center at Columbia University

location_facility: Veterans Affairs Medical Center - Memphis

location_facility: University of Mississippi Medical Center

location_facility: Veterans Affairs Medical Center - Biloxi

location_facility: Prince Edward Island Cancer Center at Queen Elizabeth Hospital

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Oklahoma University Medical Center at University of Oklahoma Health Sciences Center

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

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

location_facility: Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

location_facility: Veterans Affairs Medical Center - Little Rock (McClellan)

location_facility: University of Colorado Cancer Center at University of Colorado Health Sciences Center

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Universitat des Saarlandes Innere Medizin 1

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: University of California Davis Cancer Center

location_facility: University of Tennessee Cancer Institute

location_facility: Sunnybrook and Women's College Health Sciences Centre

location_facility: Veterans Affairs Outpatient Clinic - Martinez

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

location_facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center

location_facility: Veterans Affairs Medical Center - Salt Lake City

location_facility: Veterans Affairs Medical Center - Jackson

location_facility: Louisiana State University Health Sciences Center - Shreveport

location_facility: Hamilton and District Urology Association

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Northwestern Ontario Regional Cancer Care

location_facility: Southwest Cancer and Research Center at University Medical Center

location_facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

location_facility: Veterans Affairs Medical Center - Cincinnati

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: USC/Norris Comprehensive Cancer Center and Hospital


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

ReferenceType: background

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.

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.

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.

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.

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

location_facility: European Institute of Oncology - Chemo Prevention

location_facility: North-Estonian Regional Hospital Cancer Centre

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

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Istituto Nazionale per la Ricerca sul Cancro

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

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

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

location_facility: Otto - Von - Guericke - Universitaet Magdeburg

location_facility: Velindre Cancer Center at Velinde Hospital

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

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Selly Oak Hospital at University Hospital NHS Trust

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

location_facility: Centro di Riferimento Oncologico - Aviano

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

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Universitaet Leipzig - Chirurgische Klinik und Poliklinik I

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

status_simplified: Unknown


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.

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.

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.

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

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

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hopital de la Croix Rouge Francaise des Peupliers

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospital General Robert Ballanger

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Centre Hospital Universitaire Hop Huriez

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

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

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire Vaudois

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


title: A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

ReferenceCitation: Le Péchoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.

ReferenceCitation: Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

ReferenceCitation: Le Péchoux C, Laplanche A, Faivre-Finn C, Ciuleanu T, Wanders R, Lerouge D, Keus R, Hatton M, Videtic GM, Senan S, Wolfson A, Jones R, Arriagada R, Quoix E, Dunant A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2011 May;22(5):1154-1163. doi: 10.1093/annonc/mdq576. Epub 2010 Dec 7.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Cancer Therapy Centre at Campbelltown Hospital

location_facility: Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

location_facility: Institute of Oncology at Vilnius University

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

location_facility: Institutul Oncologic - Universitatea de Medicina

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Velindre Cancer Center at Velinde Hospital

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

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: M.D. Anderson Cancer Center at University of Texas

location_facility: First Medical Clinic of Charles University Hospital

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre Hospital Regional Universitaire de Limoges

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

location_facility: Hopital d'Instruction des Armes Sainte-Anne

intervention_type: Radiation

lead_sponsor_type: academique


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 Spain Netherlands France Belgium Germany

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Centre Hospitalier General - St. Nicolas

location_facility: Centre Hospitalier de Chalons - en - Champagne

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Hospital Universitari Sant Joan d'Alacant

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Hospital General Universitario De Guadalajara

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

intervention_type: Procedure


title: Nephroblastoma Clinical Trial and Study

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

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.

enrollment_type: Anticipated

ReferenceCitation: Sudour H, Audry G, Schleimacher G, Patte C, Dussart S, Bergeron C. Bilateral Wilms tumors (WT) treated with the SIOP 93 protocol in France: epidemiological survey and patient outcome. Pediatr Blood Cancer. 2012 Jul 15;59(1):57-61. doi: 10.1002/pbc.24059. Epub 2012 Jan 11.

ReferenceCitation: Warmann SW, Nourkami N, Frühwald M, Leuschner I, Schenk JP, Fuchs J, Graf N. Primary lung metastases in pediatric malignant non-Wilms renal tumors: data from SIOP 93-01/GPOH and SIOP 2001/GPOH. Klin Padiatr. 2012 Apr;224(3):148-52. doi: 10.1055/s-0032-1304600. Epub 2012 Apr 18.

ReferenceCitation: Furtwängler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rübe C, Siemer S, Leuschner I, Graf N. Update on relapses in unilateral nephroblastoma registered in 3 consecutive SIOP/GPOH studies - a report from the GPOH-nephroblastoma study group. Klin Padiatr. 2011 May;223(3):113-9. doi: 10.1055/s-0031-1275293. Epub 2011 Apr 20.

ReferenceCitation: van den Heuvel-Eibrink MM, van Tinteren H, Rehorst H, Coulombe A, Patte C, de Camargo B, de Kraker J, Leuschner I, Lugtenberg R, Pritchard-Jones K, Sandstedt B, Spreafico F, Graf N, Vujanic GM. Malignant rhabdoid tumours of the kidney (MRTKs), registered on recent SIOP protocols from 1993 to 2005: a report of the SIOP renal tumour study group. Pediatr Blood Cancer. 2011 May;56(5):733-7. doi: 10.1002/pbc.22922. Epub 2010 Dec 22.

ReferenceCitation: Warmann SW, Furtwängler R, Blumenstock G, Armeanu S, Nourkami N, Leuschner I, Schenk JP, Graf N, Fuchs J. Tumor biology influences the prognosis of nephroblastoma patients with primary pulmonary metastases: results from SIOP 93-01/GPOH and SIOP 2001/GPOH. Ann Surg. 2011 Jul;254(1):155-62. doi: 10.1097/SLA.0b013e318222015e.

ReferenceCitation: van den Heuvel-Eibrink MM, Grundy P, Graf N, Pritchard-Jones K, Bergeron C, Patte C, van Tinteren H, Rey A, Langford C, Anderson JR, de Kraker J. Characteristics and survival of 750 children diagnosed with a renal tumor in the first seven months of life: A collaborative study by the SIOP/GPOH/SFOP, NWTSG, and UKCCSG Wilms tumor study groups. Pediatr Blood Cancer. 2008 Jun;50(6):1130-4.

ReferenceCitation: Luithle T, Szavay P, Furtwängler R, Graf N, Fuchs J; SIOP/GPOH Study Group. Treatment of cystic nephroma and cystic partially differentiated nephroblastoma--a report from the SIOP/GPOH study group. J Urol. 2007 Jan;177(1):294-6.

ReferenceCitation: Szavay P, Luithle T, Graf N, Furtwängler R, Fuchs J. Primary hepatic metastases in nephroblastoma--a report of the SIOP/GPOH Study. J Pediatr Surg. 2006 Jan;41(1):168-72; discussion 168-72.

ReferenceCitation: Boccon-Gibod LA. Pathological evaluation of renal tumors in children: international society of pediatric oncology approach. Pediatr Dev Pathol. 1998 May-Jun;1(3):243-8.

ReferenceCitation: Fuchs J, Kienecker K, Furtwängler R, Warmann SW, Bürger D, Thürhoff JW, Hager J, Graf N. Surgical aspects in the treatment of patients with unilateral wilms tumor: a report from the SIOP 93-01/German Society of Pediatric Oncology and Hematology. Ann Surg. 2009 Apr;249(4):666-71. doi: 10.1097/SLA.0b013e31819ed92b.

ReferenceCitation: Furtwangler R, Reinhard H, Beier R, et al.: Clear-cell sarcoma (CCSK) of the kidney - results of the SIOP 93-01/GPOH trial. [Abstract] Pediatr Blood Cancer 45 (4 Suppl 1): A-0.155, 423, 2005.

ReferenceCitation: Ora I, van Tinteren H, Bergeron C, de Kraker J; SIOP Nephroblastoma Study Committee. Progression of localised Wilms' tumour during preoperative chemotherapy is an independent prognostic factor: a report from the SIOP 93-01 nephroblastoma trial and study. Eur J Cancer. 2007 Jan;43(1):131-6. Epub 2006 Nov 2.

ReferenceCitation: Reinhard H, Aliani S, Ruebe C, Stöckle M, Leuschner I, Graf N. Wilms' tumor in adults: results of the Society of Pediatric Oncology (SIOP) 93-01/Society for Pediatric Oncology and Hematology (GPOH) Study. J Clin Oncol. 2004 Nov 15;22(22):4500-6.

ReferenceCitation: Reinhard H, Semler O, Bürger D, Bode U, Flentje M, Göbel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stöckle M, Thüroff JW, Tröger J, Weirich A, von Schweinitz D, Zoubek A, Graf N. Results of the SIOP 93-01/GPOH trial and study for the treatment of patients with unilateral nonmetastatic Wilms Tumor. Klin Padiatr. 2004 May-Jun;216(3):132-40.

ReferenceCitation: Verschuur AC, Vujanic GM, Van Tinteren H, Jones KP, de Kraker J, Sandstedt B. Stromal and epithelial predominant Wilms tumours have an excellent outcome: the SIOP 93 01 experience. Pediatr Blood Cancer. 2010 Aug;55(2):233-8. doi: 10.1002/pbc.22496.

ReferenceCitation: Vujanić GM, Harms D, Bohoslavsky R, Leuschner I, de Kraker J, Sandstedt B. Nonviable tumor tissue should not upstage Wilms' tumor from stage I to stage II: a report from the SIOP 93-01 nephroblastoma trial and study. Pediatr Dev Pathol. 2009 Mar-Apr;12(2):111-5. doi: 10.2350/08-03-0432.1. Epub 2008 Sep 23.

lead_sponsor: University of Leicester

location_country:
Denmark
Croatia
Poland
Portugal
Slovenia
Greece
Italy
Spain
Czech Republic
Sweden
France
Belgium
Norway
Netherlands
United Arab Emirates

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Haukeland Hospital - University of Bergen


title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma

summary:
RATIONALE: Surgery may be an effective treatment for neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with neuroblastoma.

lead_sponsor: Societe Internationale d'Oncologie Pediatrique

location_country:
Spain
Italy
Austria
Ireland
United Kingdom
Switzerland
France
Netherlands

location_facility: Great Ormond Street Hospital for Children

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Fondazione Istituto Nazionale dei Tumori

location_facility: Fondazione I.R.C.C.S. Policlinico San Matteo

location_facility: Azienda Ospedaliera - Universitaria di Modena

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Hospital Universitario Central de Asturias


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.

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.

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.

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.

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.

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

location_facility: South Eastern Sydney Area Health Service

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Centre Hospital General Robert Ballanger

location_facility: Athens University-Laikon General Hospital

location_facility: Comprehensive Cancer Center at JFK Medical Center

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre de Radiologie et de Traitement des Tumeurs

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

location_facility: Chest Disease Clinic, Charles University

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud

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


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.

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.

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

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Istanbul University-Institute of Oncology

location_facility: Department of Dematology, Hannover Medical School

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Universitatshautklinik Eberhard - Karlsuniversitat Tubingen

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Academisch Ziekenhuis der Vrije Universiteit

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

location_facility: Tel-Aviv Medical Center-Ichilov Hospital

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.

ReferenceCitation: Aleman BM, Raemaekers JM, Tomiŝiĉ R, Baaijens MH, Bortolus R, Lybeert ML, van der Maazen RW, Girinsky T, Demeestere G, Lugtenburg P, Lievens Y, de Jong D, Pinna A, Henry-Amar M; European Organization for Research and Treatment of Cancer (EORTC) Lymphoma Group. Involved-field radiotherapy for patients in partial remission after chemotherapy for advanced Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):19-30. Epub 2006 Nov 9.

ReferenceCitation: Aleman BM, Girinsky T, van der Maazen RW, Strijk S, Meijnders P, Bortolus R, Olofsen-van Acht MJ, Lybeert ML, Lievens Y, Eghbali H, Noordijk EM, Tomsic R, Meerwaldt JH, Poortmans PM, Smit WG, Pinna A, Henry-Amar M, Raemaekers JM; European Organization for Research; Treatment of Cancer (EORTC) Lymphoma Group. Quality control of involved-field radiotherapy in patients with advanced Hodgkin's lymphoma (EORTC 20884). Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1184-90. Epub 2005 Jun 2.

ReferenceCitation: Aleman BMP, Girinsky T, Strijk S, et al.: Quality control of involved-field radiotherapy in patients with advanced stage Hodgkin's lymphoma (HL) enrolled on the EORTC trial 20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A02, 42, 2004.

ReferenceCitation: Aleman BMP, Raemaekers JMM, Tomsic R, et al.: Radiotherapy in advanced Hodgkin lymphoma (HL) patients in partial remission (PR) after chemotherapy: detailed results from the EORTC lymphoma group trial no.20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A01, 42, 2004.

ReferenceCitation: Aleman BM, Raemaekers JM, Henry-Amar M, et al.: Involved-field radiotherapy in patients with stage III/IV Hodgkin's lymphoma: first results of the randomised EORTC trial # 20884. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-3, 2, 2001.

ReferenceCitation: Raemaekers J, Burgers M, Henry-Amar M, Pinna A, Mandard A, Monfardini S, Hagenbeek A, Breed W, Carde P, Vovk M, van Hoof A, Thomas J, Noordijk E. Patients with stage III/IV Hodgkin's disease in partial remission after MOPP/ABV chemotherapy have excellent prognosis after additional involved-field radiotherapy: interim results from the ongoing EORTC-LCG and GPMC phase III trial. The EORTC Lymphoma Cooperative Group and Groupe Pierre-et-Marie-Curie. Ann Oncol. 1997;8 Suppl 1:111-4.

location_country: Poland Portugal Slovenia Italy Netherlands France Belgium Germany Egypt

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Centro di Riferimento Oncologico - Aviano


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.

status: 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.

ReferenceCitation: Gratl A; European Vascular Research Collaborative (EVRC). Study Protocol of a Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia. J Surg Res. 2022 Nov 5;282:280-284. doi: 10.1016/j.jss.2022.09.023. [Epub ahead of print]

ipd_sharing: No

lead_sponsor: Medical University Innsbruck

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

location_facility: Department of Vascular Surgery, Medical University Graz

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

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

location_facility: Department of Vascular and Endovascular Surgery, Hospital Ottakring

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

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

location_facility: Department of Surgery, Medical Faculty Mannheim

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

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

location_facility: Dijklander hospital, Department of Surgery

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

location_facility: Institute for Cardiovascular Disease, Belgrade

location_facility: Department of Vascular Surgery, University Hospital of Nancy

location_facility: Department of Vascular Surgery, LKH Feldkirch

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

location_facility: Amsterdam University Medical Center, Department of Surgery

location_facility: Department of Vascular Surgery, Kantonsspital Winterthur

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

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

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

location_facility: Department of Vascular Surgery, Bordeaux University Hospital

location_facility: Department of Vascular Surgery, University Hospital Wales

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

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: 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: Medical University of Innsbruck, Department of Vascular Surgery

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

location_facility: Vascular Surgery Department, Algarve University Medical Centre

location_facility: Clinic for Vascular Surgery, Clinical Center Niš

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

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

location_facility: Department of Vascular Surgery, CHU de Reims

location_facility: Department of Vascular Surgery, University Hospital of Nice

location_facility: Department of Vascular Surgery, Henri Mondor University Hospital

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

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

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

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

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

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

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, University Hospital of Besançon

location_facility: Department of Vascular Surgery, University Hospital of Dijon

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

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

location_facility: University Medical Center Utrecht, Department of Vascular Surgery

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

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

location_facility: Vascular Surgery Department, Hospices Civils de Lyon

intervention_type: Other


title: Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

acronym: PsABIOnd

summary: The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Austria
Australia
Russian Federation
Argentina
Mexico
Sweden
Brazil
Canada
Switzerland
Germany
Taiwan
Greece
Korea, Republic of
France
Colombia
Netherlands

location_facility: North-Western State Medical University named I.I. Mechnikov

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Schwerpunktpraxis für Rheumatologie und Klinische Immunologi

location_facility: FGBU Research Institute of Rheumatology named V.A.Nasonova

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation

location_facility: Bakoulev Scientific Center For Cardiovascular Surgery Rams

location_facility: University General Hospital of Rio Patras

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale

location_facility: Soonchunhyang University Cheonan Hospital

location_facility: Brandusa Florica Medicine Professional Corporation

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Republican Hospital named by V.A.Baranova

location_facility: Praxis fur Klinische Studien und Praxis fur Orthopadie

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

location_facility: NHS Grampian - Aberdeen Royal Infirmary (ARI)

location_facility: Ospedale Regionale Cardarelli-Università degli Studi del Mol

location_facility: CHR Orléans - Nouvel Hôpital Orléans La Source

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Centre de Recherche Musculo Squelettique

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

location_facility: Seoul National University Bundang Hospital

location_facility: Hôpital Lariboisière - Centre Viggo Petersen

location_facility: CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Toho University Medical Center, Ohashi Hospital

location_facility: Akademiskt Specialistcentrum centrum för reumatologi

location_facility: Praxis Prim. Priv.Doz. Dr. Burkhard Leeb

location_facility: Evang. Krankenhaus Gemein. Betriebgesm. Mbh

location_facility: 'Agios Andreas' General Hospital of Patras

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

location_facility: Hospital Militar Central Cir. My. Dr. Cosme Argerich


title: A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

acronym: ENDEAVOR

summary: This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction > 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 825 in Part B.

ipd_sharing: Yes

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Denmark
Poland
Taiwan
Brazil
Russian Federation
Australia
Canada
Sweden
Hungary
United States
France
Turkey
Belgium
Japan
Netherlands
Bulgaria
Slovakia
Czechia


title: A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

acronym: VOLGA

summary:
A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).

Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.

In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

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.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Hong Kong
Portugal
Austria
Russian Federation
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Germany
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity

acronym: DIRECTION

summary: This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.

ReferenceCitation: Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25.

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underline the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

lead_sponsor: Ipsen

location_country:
United States
Canada
France

location_facility: Rehabilitation Associates of the Main Line

location_facility: Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

location_facility: Siskin Hospital for Rehabilitation - Neurology

location_facility: Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Texas Institute for Neurological Disorders

location_facility: HonorHealth Scottsdale Osborn Medical Center

location_facility: Ki Health Partners LLC D/B/A New England Institute for Clinical Research

location_facility: Hopital Albert Chennevier (CHU Henri Mondor)

location_facility: North Texas Institute of Neurology & Headache

location_facility: Parkinson's Disease Treatment Center of S.W. Florida

location_facility: Parkinson's & Movement Disorders Institute

location_facility: Centre Hospitalier de Saint Amand Montrond


status: Enrolling by invitation

acronym: BE HEARD EXT

title: A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

lead_sponsor: UCB Biopharma SRL

source: euctr

design_allocation: Non-Randomized

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Poland
Spain
Greece
Ireland
Australia
Italy
Canada
Netherlands
Switzerland
United Kingdom
Hungary
United States
France
Israel
Turkey
Belgium
Japan
Germany
Bulgaria
Czechia

summary: The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

acronym: HYPERION

summary: The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

lead_sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: University of Cincinnati Health ( Site 1035)

location_facility: Norrlands Universitetssjukhus ( Site 3205)

location_facility: Instituto Cardiovascular de Rosario ( Site 1906)

location_facility: Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: Waikato District Health Board ( Site 2702)

location_facility: Hospital Universitario de Son Espases ( Site 1611)

location_facility: Fundacion Neumologica Colombiana ( Site 3403)

location_facility: Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2201)

location_facility: Evangelismos General Hospital of Athens ( Site 3605)

location_facility: Oregon Health & Science University ( Site 1054)

location_facility: Universitatsklinikum Leipzig ( Site 1508)

location_facility: Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)

location_facility: Severance Hospital Yonsei University Health System - PPDS ( Site 3101)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3902)

location_facility: Sir Mortimer B. Davis Jewish General Hospital ( Site 2103)

location_facility: Washington University School of Medicine ( Site 1022)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 3104)

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

location_facility: University of California Irvine ( Site 1086)

location_facility: Azienda Policlinico Umberto I ( Site 2402)

location_facility: Gachon University Gil Medical Center ( Site 3103)

location_facility: Hospital Universitari Vall de Hebron ( Site 1605)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1501)

location_facility: University Hospital Centre Split city ( Site 3901)

location_facility: Papworth Hospital NHS Foundation Trust ( Site 1208)

location_facility: Hopital de la Cote de Nacre - Caen ( Site 1325)

location_facility: Hopitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: CHU de Nantes - Hôptal Nord Laennec ( Site 1309)

location_facility: Universitatsklinikum des Saarlandes ( Site 1513)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 2802)

location_facility: St Boniface General Hospital ( Site 2106)

location_facility: Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)

location_facility: Radboud University Nijmegen Medical Centre ( Site 2605)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

location_facility: Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

location_facility: National Cheng Kung University Hospital ( Site 3703)

location_facility: Seoul National University Hospital ( Site 3102)

location_facility: AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

location_facility: Hospital Universitario La Paz ( Site 1610)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: Aarhus Universitetshospital, Skejby ( Site 3801)

location_facility: Golden Jubilee National Hospital ( Site 1204)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 3404)

location_facility: University of California San Diego ( Site 1002)

location_facility: Medical University of South Carolina ( Site 1003)

location_facility: Chonnam National University Hospital ( Site 3105)

location_facility: Princess Alexandra Hospital ( Site 1108)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Onassis Cardiac Surgery Center ( Site 3602)

location_facility: Centro Hospitalar E Universitário De Coimbra ( Site 3502)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1601)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

location_facility: University of Alberta Hospital ( Site 2101)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 3601)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: Skanes Universitetssjukhus Lund ( Site 3203)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: China Medical University Hospital ( Site 3701)

location_facility: University of Iowa Hospital and Clinics ( Site 1050)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: Attikon University General Hospital of Athens ( Site 3604)

location_facility: Kaohsiung Veterans General Hospital ( Site 3702)

location_facility: Hospital Provincial del Centenario ( Site 1912)

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

location_facility: CHRU Brest - Hopital Cavale Blanche ( Site 1314)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: Instituto do Coracao - HCFMUSP ( Site 1803)

location_facility: Institut Klinicke a Experimentalni Mediciny ( Site 2202)

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 1303)

location_facility: Hospital Universitario de Toledo ( Site 1607)

location_facility: Instituto Medico Rio Cuarto ( Site 1907)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome (SELECT MDS-1)

summary: This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.

lead_sponsor: Syros Pharmaceuticals

location_country:
Poland
Spain
Italy
Austria
Canada
Hungary
United States
France
Belgium
Czechia

location_facility: Morristown Medical Center- Atlantic Hematology Oncology

location_facility: University of Utah Huntsman Cancer Institute

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_facility: Centre Hospitalier de la Côte Basque Hématologie Clinique

location_facility: Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Montefiore Medical Center & Albert Einstein College of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitario Central de Asturia

location_facility: American Oncology Partners of Maryland, PA

location_facility: SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)

location_facility: Hospital Universitario Marqués de Valdecilla