PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
low-LET photon therapy
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1992
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse. Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease. OUTLINE: This is a randomized study. Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks. Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy. Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter. PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.1005 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA At least 1 of the following features must be present: Complete capsule invasion (i.e., perforation) Positive surgical margins (microscopic or gross) Seminal vesicle invasion Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No more than 4 months of preoperative hormonal therapy Radiotherapy: Not specified Surgery: Radical prostatectomy required within 12 weeks with recovery of urinary function
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site