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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00667069 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: triptorelin Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk. |
Estimated Enrollment: | 718 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2022 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Must have undergone curative surgery in the past 6 months
No current clinical or biochemical disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Contact Person 33-3-8359-8400 | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Contact Person 33-2-3208-2222 | |
Centre Hospitalier Lyon Sud | Recruiting |
Pierre Benite, France, 69495 | |
Contact: Contact Person 33-4-78-86-11-58 | |
Centre Hospitalier Universitaire Henri Mondor | Recruiting |
Creteil, France, 94000 | |
Contact: Contact Person 33-1-49-812-590 | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Contact Person 33-4-78-78-26-45 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Contact: Contact Person 33-4-6761-3100 | |
Centre Regional Francois Baclesse | Recruiting |
Caen, France, 14076 | |
Contact: Contact Person 33-2-3145-5000 | |
Centre Regional Rene Gauducheau | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Contact Person 33-2-40-479-959 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Contact Person 33-1-4211-4339 | |
Clinique du Pont de Chaume | Recruiting |
Montauban, France, 82017 | |
Contact: Contact Person 33-563-683-490 | |
Hopital Europeen Georges Pompidou | Recruiting |
Paris, France, 75015 | |
Contact: Contact Person 33-56-09-20-00 | |
Hopital Saint Andre | Recruiting |
Bordeaux, France, 33075 | |
Contact: Contact Person 33-5-5679-5808 | |
Hopitaux Civils de Colmar | Recruiting |
Colmar, France, 68024 | |
Contact: Contact Person 33-3-8912-4000 | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Contact Person 33-5-5633-3320 | |
Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Contact: Contact Person 33-5-6142-4242 | |
Institut de Cancerologie de la Loire | Recruiting |
Saint Priest en Jarez, France, 42270 | |
Contact: Contact Person 33-477-91-7000 | |
CHU Poitiers | Recruiting |
Poitiers, France, 86021 | |
Contact: Contact Person 33-549-444-538 |
Study Chair: | Pierre Richaud, MD | Institut Bergonie |
Study ID Numbers: | CDR0000577485, FNCLCC-GETUG-17/0702, EU-20791, EUDRACT-2007-002495-34 |
Study First Received: | April 24, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00667069 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer |
Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Contraceptive Agents Triptorelin Contraceptive Agents, Female |
Adjuvants, Immunologic Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptive Agents, Female Urogenital Neoplasms Reproductive Control Agents |
Genital Diseases, Male Luteolytic Agents Pharmacologic Actions Neoplasms Neoplasms by Site Triptorelin Therapeutic Uses Prostatic Neoplasms |