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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-GETUG-01 | |||
| EU-98029 |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).
Patients are randomized to one of two treatment arms.
Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.
Patients are followed at 2 and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate
Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria:
Good prognosis defined as meeting 1 of the following criteria:
No metastases by bone scans or chest x-ray
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Pommier, MD | Centre Leon Berard | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Centre Hospitalier d'Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18048817 | Result | Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171. | |
| Result | Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005. |
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| Annecy |
| 74011 Cedex |
| France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre de Radiotherapie du Parc | Chalon-sur-Saône | 71100 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Clinique de la Sauvegarde - Clinique Jeanne D'Arc | Lyon | 69008 | France |
| Clinique de la Sauvegarde | Lyon | 69008 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| CHR D'Orleans - Hopital de la Source | Orléans | 45067 | France |
| Hopital d'Instruction des Armees du Val de Grace | Paris | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Eugene Marquis | Rennes | 35064 | France |
| CHG Roanne | Roanne | F-42300 | France |
| Clinique de l'Orangerie | Strasbourg | 67010 | France |
| Centre Paul Strauss | Strasbourg | 67085 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Marie Curie | Valance | 26000 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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