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

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

status: Approved for marketing

study_type: Expanded Access

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

location_facility: 1182.58.61002 Royal North Shore Hospital

location_facility: 1182.58.3204 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.35102 Hospital Condes Castro Guimarães

location_facility: 1182.58.4505 Aarhus Universitetshospital Skejby

location_facility: 1182.58.44028 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27097 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.4107 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61017 Department of Infectious Diseases

location_facility: 1182.58.44030 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44003 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44008 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44002 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44014 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44011 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44029 Our Lady For Sick Children

location_facility: 1182.58.44010 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27098 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.3201 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27099 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44023 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.039 Olmos Park Medical Associates

location_facility: 1182.58.44025 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.4104 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44031 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44019 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.3203 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44026 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44018 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44005 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.23 Hillsborough County Health Department

location_facility: 1182.58.61013 Melbourne Sexual Health Clinic

location_facility: 1182.58.18 University of Texas Southwest Medical Center at Dallas

location_facility: 1182.58.44024 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27095 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61016 Princess Alexandra Hospital

location_facility: 1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: 1182.58.4103 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.61001 88 Rathdowne Street Carlton

location_facility: 1182.58.44004 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44017 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.27096 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.01 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.4105 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.33017 Hôpital Bichat Claude Bernard

location_facility: 1182.58.61018 Melbourne Sexual Health Clinic

location_facility: 1182.58.44022 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.06 University of Cincinnati Medical Center, Infectious diseases

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

location_facility: 1182.58.3906 Ospedale Infantile Regina Margherita

location_facility: 1182.58.4101 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.44009 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.04 Kansas City Free Health Clinic

location_facility: 1182.58.61005 Royal Prince Alfred Hospital

location_facility: 1182.58.61003 The Prince of Wales Hospital

location_facility: 1182.58.3907 Presidio Ospedaliero di Rimini

location_facility: 1182.58.44027 Boehringer Ingelheim Investigational Site

location_facility: 1182.58.40 Drs. Raben and Feldman Research Associates

location_facility: 1182.58.4102 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

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.

ReferenceCitation: G Andriole, D Bostwick, O Brawley, L Gomella, M Marberger, F Montorsi, C Pettaway, T Tammela, C Teloken, D Tindall, M Somerville, I Fowler and R Rittmaster on behalf of the REDUCE Study Group. Risk reduction in men at increased risk: outcomes of the REduction by Dutasteride of prostate Cancer Events (REDUCE) trial. [N Engl J Med]. 2010;362(13):1192-202.

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: 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: 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: Jean-Alfred Thomas, II, Leah Gerber, Lionel Banez, Daniel Moreira,Ramiro Castro, Gerald L. Andriole and Stephen J. Freedland. Prostate Cancer Risk in Men with Prostate and Breast Cancer Family History: Results from the REDUCE study. [J Intern Med [Epub Dec 28 2011]]. 2011;

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, Banez 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.

ReferenceType: derived

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.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

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.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

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.

publisher_dissemination: Wolters Kluwer Health

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.

publisher_dissemination: Wiley

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.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

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.

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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

primary_purpose: Treatment

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.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

collaborators: Grup per l'Estudi dels Limfomes de Catalunya i Balears

collaborators: Australasian Leukaemia and Lymphoma Group

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

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

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: McGill Cancer Centre at McGill University

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Nepean Cancer Care Centre at Nepean Hospital

location_facility: Karolinska University Hospital - Huddinge

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Saskatoon Cancer Centre at the University of Saskatchewan

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Centre Hospitalier Regional de la Citadelle

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

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centre Hospitalier Universitaire Brugmann

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

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital


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.

lead_sponsor: Eli Lilly and Company

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

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.


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.

lead_sponsor: Pfizer

collaborators: International Collaborative Cancer Group

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


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, et al.: Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy: EORTC30987/Intergroup study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5030, 242s, 2007.

collaborators: Groupe D'Etude des Tumeurs Uro-Genitales

collaborators: Institute of Cancer Research, United Kingdom

collaborators: Central European Cooperative Oncology Group

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

sponsor_collaborators: Groupe D'Etude des Tumeurs Uro-Genitales

sponsor_collaborators: Institute of Cancer Research, United Kingdom

sponsor_collaborators: Central European Cooperative Oncology Group

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

location_facility: Josephine Ford Cancer Center at Henry Ford Hospital

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

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

location_facility: Veterans Affairs Medical Center - Lexington

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Veterans Affairs Medical Center - Jackson

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

location_facility: Veterans Affairs Medical Center - Kansas City

location_facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

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

location_facility: Veterans Affairs Medical Center - Salt Lake City

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Klinik und Poliklinik fuer Kinderheilkunde

location_facility: Hollings Cancer Center at Medical University of South Carolina

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Herbert Irving Comprehensive Cancer Center at Columbia University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center

location_facility: Veterans Affairs Medical Center - New Orleans

location_facility: Universitat des Saarlandes Innere Medizin 1

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Veterans Affairs Medical Center - Charleston

location_facility: Centre Hospitalier Regional de Lanaudiere

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

location_facility: Algoma Reginal Cancer Program at Sault Area Hospital

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

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Providence Cancer Institute at Providence Hospital

location_facility: Charles M. Barrett Cancer Center at University Hospital

location_facility: Prostate Centre at Vancouver General Hospital

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

location_facility: Veterans Affairs Medical Center - Tucson

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

location_facility: Veterans Affairs Medical Center - Ann Arbor

location_facility: University of Tennessee Cancer Institute

location_facility: University of Texas Health Science Center at San Antonio

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Veterans Affairs Medical Center - Seattle

location_facility: Veterans Affairs Medical Center - Memphis

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

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Sunnybrook and Women's College Health Sciences Centre

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: USC/Norris Comprehensive Cancer Center and Hospital

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Hospitalier Universitaire Henri Mondor

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

location_facility: Krankenhaus Hohe Warte Mediziniche Klinik

location_facility: Veterans Affairs Medical Center - Biloxi

location_facility: Durham Regional Cancer Centre at Lakeridge Health Oshawa

location_facility: Veterans Affairs Medical Center - Cincinnati

location_facility: Hospital General Universitario De Guadalajara

location_facility: Cancer Research Center at Boston Medical Center

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

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

location_facility: Jonsson Comprehensive Cancer Center, UCLA

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

location_facility: Louisiana State University Health Sciences Center - Shreveport

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Veterans Affairs Medical Center - Shreveport

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Northwestern Ontario Regional Cancer Care

location_facility: St. Louis University Hospital Cancer Center

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

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

location_facility: Prince Edward Island Cancer Center at Queen Elizabeth Hospital

location_facility: Veterans Affairs Medical Center - Portland

location_facility: Cancer Care Ontario - Windsor Regional Cancer Centre

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Veterans Affairs Outpatient Clinic - Martinez

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Veterans Affairs Medical Center - Amarillo

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Cancer Institute at Oregon Health and Science University

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

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Northeastern Ontario Regional Cancer Centre - Sudbury

location_facility: University of Mississippi Medical Center

location_facility: Veterans Affairs Medical Center - Oklahoma City

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Velindre Cancer Center at Velinde Hospital

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

location_facility: Hamilton and District Urology Association

location_facility: Southwest Cancer and Research Center at University Medical Center

location_facility: University of California Davis Cancer Center


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

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

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

status: Unknown status

ReferenceCitation: Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Sales 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, Sales 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, Sales 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, Sales 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:
France
Germany
Italy
Poland
Portugal
Slovenia
Israel
United Kingdom
Australia
Netherlands
Switzerland
Belgium
Spain
Turkey
Croatia
Bulgaria
Estonia
Czech Republic

location_facility: North-Estonian Regional Hospital Cancer Centre

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Otto - Von - Guericke - Universitaet Magdeburg

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

location_facility: Centre Hospitalier Regional Metz Thionville

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

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

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: European Institute of Oncology - Chemo Prevention

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

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

location_facility: Universitaet Leipzig - Chirurgische Klinik und Poliklinik I

location_facility: Centro di Riferimento Oncologico - Aviano

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

location_facility: Selly Oak Hospital at University Hospital NHS Trust

location_facility: Centre Hospital Regional Universitaire de Limoges

intervention_type: Procedure


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

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

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

status: Active, not recruiting

ReferenceCitation: van der Kaaij MA, Heutte N, van Echten-Arends J, Raemaekers JM, Carde P, Noordijk EM, Ferme 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, Ferme 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. doi: 10.1200/JCO.2006.10.2020. 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, Ferme C, Noordijk EM, Morschhauser F, Girinsky T, Gaillard I, Lugtenburg PJ, Andre M, Lybeert MLM, Stamatoullas A, Beijert M, Helias 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.

oa_host_type: repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: green

ReferenceCitation: Ferme 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, Briere J, Henry-Amar M; European Organisation for Research and Treatment of Cancer Lymphoma Group, and; Groupe d'Etude des Lymphomes de l'Adulte. ABVD or BEACOPPbaseline 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'Etude 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.

collaborators:
Lymphoma Study Association
UNICANCER

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

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

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre Hospitalier Sud Francilien - Site Corbeil

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Centre Hospital General Robert Ballanger

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Hopital Cantonal Universitaire de Geneve

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

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

location_facility: Hopital de la Croix Rouge Francaise des Peupliers

status_simplified: Ongoing


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 Pechoux 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 Pechoux 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

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

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Hopital d'Instruction des Armes Sainte-Anne

location_facility: Cancer Research Centre at Weston Park Hospital

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

location_facility: Institutul Oncologic - Universitatea de Medicina

location_facility: First Medical Clinic of Charles University Hospital

location_facility: Institute of Oncology at Vilnius University

location_facility: Cancer Therapy Centre at Campbelltown Hospital

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

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

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

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

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Velindre Cancer Center at Velinde Hospital

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, Strater J, Buchholz M, Aust DE, Julie C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Kohne 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. doi: 10.1186/1471-2407-7-58.

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

collaborators: Federation Francophone de Cancerologie Digestive

collaborators: Grupo Espanol Tratamiento Tumores Digestivos

location_country: Germany Netherlands Belgium Spain Serbia France

location_facility: Centre Hospitalier General - St. Nicolas

location_facility: Centre Hospitalier General de Saint Nazaire

location_facility: Hospital Universitari Sant Joan d'Alacant

location_facility: Hospital General Universitari Vall d'Hebron

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

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier de Bourgoin - Jallieu

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Hospital General Universitario De Guadalajara

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre Hospitalier de Chalons - en - Champagne

location_facility: Centre Hospitalier Universitaire de Dijon


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, Fruhwald 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: Furtwangler R, Nourkami N, Alkassar M, von Schweinitz D, Schenk JP, Rube 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, Furtwangler 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. doi: 10.1002/pbc.21389.

ReferenceCitation: Luithle T, Szavay P, Furtwangler 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. doi: 10.1016/j.juro.2006.09.011.

ReferenceCitation: Szavay P, Luithle T, Graf N, Furtwangler 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. doi: 10.1016/j.jpedsurg.2005.10.021.

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. doi: 10.1007/s100249900033.

ReferenceCitation: Fuchs J, Kienecker K, Furtwangler R, Warmann SW, Burger D, Thurhoff 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. doi: 10.1016/j.ejca.2006.08.033. Epub 2006 Nov 2.

ReferenceCitation: Reinhard H, Aliani S, Ruebe C, Stockle 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. doi: 10.1200/JCO.2004.12.099.

ReferenceCitation: Reinhard H, Semler O, Burger D, Bode U, Flentje M, Gobel U, Gutjahr P, Leuschner I, Maass E, Niggli F, Scheel-Walter HG, Stockle M, Thuroff JW, Troger 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. doi: 10.1055/s-2004-822625.

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

location_facility: Haukeland Hospital - University of Bergen

location_facility: Academisch Ziekenhuis der Vrije Universiteit


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:
Ireland
Italy
United Kingdom
Netherlands
Austria
Switzerland
Spain
France

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Azienda Ospedaliera - Universitaria di Modena

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

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Hospital Universitario Central de Asturias

location_facility: Great Ormond Street Hospital for Children

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Fondazione Istituto Nazionale dei Tumori

location_facility: Centre Hospital Regional Universitaire de Limoges


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, Seve 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. doi: 10.1097/01.cco.0000208787.91947.a2.

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. doi: 10.3816/CLC.2006.n.028.

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 Pechoux 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, Andre 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. doi: 10.1200/JCO.2006.08.2867.

ReferenceCitation: Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre 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. doi: 10.1056/NEJMoa060570.

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. doi: 10.1056/NEJMoa031644.

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.

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Hopital Cantonal Universitaire de Geneva

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

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: South Eastern Sydney Area Health Service

location_facility: Centre Hospital General Robert Ballanger

location_facility: Chest Disease Clinic, Charles University

location_facility: Athens University-Laikon General Hospital

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

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

location_facility: Centre de Radiologie et de Traitement des Tumeurs

location_facility: Comprehensive Cancer Center at JFK Medical Center

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


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, Sales 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, Sales 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. doi: 10.2165/00128071-200304080-00002.

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-alpha (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, Sales F, Stoitchkov K, Patel P, Cocquyt V, Thomas J, Lienard 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. doi: 10.1016/S0140-6736(05)67482-X.

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

location_facility: Tel-Aviv Medical Center-Ichilov Hospital

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Regional et Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Universitatshautklinik Eberhard - Karlsuniversitat Tubingen

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

location_facility: Russian Academy of Medical Sciences Cancer Research Center

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

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Istanbul University-Institute of Oncology

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Department of Dematology, Hannover Medical School

intervention_type: Biological


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, Tomisic 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. doi: 10.1016/j.ijrobp.2006.08.041. 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. doi: 10.1016/j.ijrobp.2005.03.044. 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: Germany Italy Poland Slovenia Portugal Netherlands Belgium Egypt France

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

location_facility: University Hospital - Rotterdam Dijkzigt


title: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

summary: The intention of the study is to demonstrate superiority of AZD5305 + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

status: Recruiting

study_completion_date_type: Anticipated

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

lead_sponsor: AstraZeneca

location_country:
Finland
Germany
Poland
Australia
Brazil
Thailand
Turkey
Chile
Canada
France
Hungary
United States
India
Belgium
China
Malaysia
Peru
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden


title: A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

summary: This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

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

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Germany
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Canada
France
Hungary
Hong Kong
Switzerland
United States
India
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Bulgaria


title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

acronym: REPLENISH

summary: The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
Denmark
Switzerland
United States
Lebanon
Italy
Netherlands
Spain


title: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

summary: The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Severance Hospital, Yonsei University Health System

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: CIMET's Inamdar Multispeciality Hospital

location_facility: CHUM - Centre hospitalier universitaire de Montreal

location_facility: Kobe City Medical Center General Hospital

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

location_facility: Shengjing Hospital of China Medical University

location_facility: Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Thomayerova nemocnice, Onkologicka klinika

location_facility: Netaji Subhas chandra Bose Cancer Research Institute

location_facility: Hospital Regional do Cancer - Hospital de Esperança

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: CHU de Quebec-Universite Laval-Hopital de l'Enfant-Jesus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Affiliated Hospital of Ningbo University

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Ospedale San Giuseppe Moscati di Avellino

location_facility: The First Bethune Hospital of Jilin University

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Clinical Research Center sp. z o.o MEDIC-R s.k.

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Centers for Advanced Urology LLC d b a MidLantic Urology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Genesis Research, LLC - West Coast Urology

location_facility: Centro Hospitalar de Vila Nova de Gaia Espinho E P E

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: Consultorio Medico dentro del Hospital Angeles Acoxpa

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Klinikum rechts der Isar an der Technischen Universität München

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: Medizinisches Versorgungszentrum - Urologie


acronym: ODYSSEY-HCM

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

location_facility: Atlantic Medical Group Hypertrophic Cardiomyopathy

location_facility: Innovative Research Of West Florida, Inc

location_facility: University of Michigan Comprehensive Cancer Center UMCCC-Gastrointestinal Cancer Clinic

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Aventiv Research Inc - Columbus - HyperCore - PPDS

location_facility: Mayo Clinic - Cancer Center - Rochester - PPDS

location_facility: Cardiology Physicians, P.A. - Daytona Beach - Flor

location_facility: Beth Israel Deaconess Medical Center - 330 Brookline Ave

location_facility: Virginia Commonwealth University (VCU) Medical Center

location_facility: University of Maryland Faculty Physicians, Inc

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Medical University of South Carolina - PPDS

location_facility: Hennepin County Medical Center Clinic and Specialty Center

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Rutgers, the State University of New Jersey

location_facility: Medizinische Universität Graz-Auenbruggerplatz 52

location_facility: Washington University School of Medicine

location_facility: University of Rochester - Rochester General Hospital - PPDS

location_facility: USF Health South Tampa Center For Advanced Healthcare

location_facility: Great Lakes Clinical Trials, LLC - Flourish - 5149 North Ashland Ave - PPDS

location_facility: Baptist Health Medical Center - Little Rock

location_facility: Quality Clinical Research - HyperCore - PPDS

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Texas Southwestern Medical Center

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Virginia Mason Medical Center - 1100 9th Ave

location_facility: Boston Medical Center-1 Boston Medical Center Pl

location_facility: University Hospitals Cleveland Medical Center - 11100 Euclid Ave

location_facility: Midwest Cardiovascular Institute Naperville

location_facility: Moore Clinical Research, Inc. - Tampa - HyperCore - PPDS

location_facility: Meriter Hospital Heart and Vascular Institute

location_facility: Christ Hospital Physicians Heart & Vascular Center

location_facility: McGinnis Thoracic & Cardiovascular Associates - Greensburg

location_facility: Schnitzler Cardiovascular Consultants, PLCC

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Intermountain Healthcare - Southwest Cardiology -

location_facility: Hospital General Universitario Dr. Balmis

location_facility: CECAP - Centro de Cardiologia Clínica e Pesquisa D

location_facility: Stanford Health Care (SHC) - Hypertrophic Cardiomy

location_facility: IACT Health - Roswell - IACT - HyperCore - PPDS

location_facility: Wexner Medical Center at The Ohio State University

location_facility: Saint Luke's Mid America Heart Institute

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: University of California San Diego - Sulpizio Cardiovascular Center

location_facility: University of Rochester Medical Center - PPDS

location_facility: UCLA University of California Los Angeles

location_facility: St. Vincent Heart Center of Indiana (SVHCI) - 106t

location_facility: Indiana University School of Medicine-Indianapolis

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: HealthEast Heart Care Center - Saint Paul

location_facility: Virginia Commonwealth University Medical Center

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: University Of Iowa Hospitals And Clinics

location_facility: Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS

location_facility: North Shore University Hospital-300 Community Dr

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: MedStar Washington Hospital Center - Cardiovascular Research Institute (CRI)

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

location_facility: Johns Hopkins University School of Medicine

location_facility: Aventiv Research Inc. - Dublin - HyperCore - PPDS

location_facility: Icahn School of Medicine at Mount Sinai - BRANY - PPDS

location_facility: Baylor Scott and White Research Institute

title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

type: Registry Identifier

source: euctr

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
India
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Israel


title: A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY

acronym: LATIFY

summary: This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

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.

sponsor_collaborators: AstraZeneca Parexel

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
Serbia
France
Hungary
Hong Kong
United States
India
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan


title: An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

summary:
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

mFOLFOX6 alone,
mFOLFOX6 with bevacizumab, or
mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

lead_sponsor: Seagen Inc.

sponsor_collaborators:
Seagen Inc.
Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Slovakia
Switzerland
United States
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Meizhou People's Hospital - Guangdong Province

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Consorci Hospital General Universitari de Valencia (CHGUV)

location_facility: Affiliated Hospital of Chengde Medical University

location_facility: Osaka General Medical Center (Kyuseiki Sogo Iryo C)

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: The First Hospital of China Medical University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: The First People's Hospital of Changzhou

location_facility: Providence Regional Medical Center Everett

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Fujian Medical University Union Hospital

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Presido Ospedale Garibaldi - Nesima

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The First Hospital of Lanzhou University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: 900TH Hospital of Joint Logistics Support Force

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

location_facility: The Second Affiliated Hospital of Hainan Medical University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Gemeinschaftspraxis Haematologie - Onkologie: Freiberg-Richter, Jacobasch, Illmer, Wolf

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Army Specialty Medical Center of The Chinese People's Liberation Army

location_facility: Mater Misericordiae University Hospital (MMUH)

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut de Cancerologie de I'Ouest - Site Saint-Herblain

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: St. Marianna University School of Medicine

location_facility: Hospital de Cancer de Barretos - Fundacao Pio XII

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Complejo Hospitalario Universitario de Ourense (CHOU)

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Centre Hospitalier Chretien - Clinique MontLégia

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: The First Hospital Affiliated to Liaoning Medical College

location_facility: Katedra i Klinika Onkologii i Radioterapii

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centre Hospitalier Universitaire de Poitiers