Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
UNICANCER
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003607
First received: November 1, 1999
Last updated: February 18, 2011
Last verified: December 2004
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 450 |
| Study Start Date: | December 1997 |
OBJECTIVES:
- Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.
- Compare the toxic effects of these two regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the prognostic factors of progression in these patients.
- Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.
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.
- Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
- Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate
- Stage I (T1b or T1c, N0, M0)
- Stage II (T2, N0, M0)
- Stage III (T3, N0, M0)
Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria:
- Gleason score at least 7
- Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN)
- T3 OR
Good prognosis defined as meeting 1 of the following criteria:
- T1b or T2
- T1c with Gleason score less than 7 and PSA less than 3 times ULN
- No metastases by bone scans or chest x-ray
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 10 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 10 years except basal cell skin cancer
- No adenopathies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months
- No concurrent luteinizing hormone-releasing hormone agonists
- No concurrent anti-androgen therapy
- No concurrent hormonal therapy in high-risk group
Radiotherapy:
- No prior pelvic radiotherapy
Surgery:
- No prior lymphadenectomy
- No prior surgical castration
- No prior prostatectomy
- At least 1 month since prior transurethral resection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003607
Locations
| France | |
| Centre Paul Papin | |
| Angers, France, 49036 | |
| Centre Hospitalier d'Annecy | |
| Annecy, France, 74011 Cedex | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Centre de Radiotherapie du Parc | |
| Chalon Sur Saone, France, 71100 | |
| Centre Hospitalier Universitaire Henri Mondor | |
| Creteil, France, 94010 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Centre Hospital Regional Universitaire de Limoges | |
| Limoges, France, 87042 | |
| Clinique de la Sauvegarde | |
| Lyon, France, 69008 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Clinique de la Sauvegarde - Clinique Jeanne D'Arc | |
| Lyon, France, 69008 | |
| Institut J. Paoli and I. Calmettes | |
| Marseille, France, 13273 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| CHR D'Orleans - Hopital de la Source | |
| Orleans, France, 45067 | |
| Hopital d'Instruction des Armees du Val de Grace | |
| Paris, France | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| Institut Jean Godinot | |
| Reims, France, 51056 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| CHG Roanne | |
| Roanne, France, F-42300 | |
| Centre Paul Strauss | |
| Strasbourg, France, 67085 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
| Centre Marie Curie | |
| Valance, France, 26000 | |
Sponsors and Collaborators
UNICANCER
Investigators
| Study Chair: | Pascal Pommier, MD | Centre Leon Berard |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00003607 History of Changes |
| Other Study ID Numbers: | CDR0000066684, FRE-FNCLCC-GETUG-01, EU-98029 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013