A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER
BCG vaccine
+ mitomycin C
+ radiation therapy
Enfermedades Urogenitales+6
+ Enfermedades de la vejiga urinaria
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1991
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder. Determine the toxicity of radical radiotherapy in these patients. Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III. Arm I: Patients undergo observation only. Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study. Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks. Patients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Diagnosis of transitional cell carcinoma of the bladder Stage T1 Nx M0, grade 3 disease No muscle invasion at base of tumor Diagnosis of this stage made within the past 6 months Earlier diagnosis of tumors with lower stage or grade allowed No history of higher stage urothelial tumors Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed No widespread CIS causing severe symptoms Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior adjuvant treatment with intravesical BCG Chemotherapy: No more than 1 prior adjuvant treatment with intravesical chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Diathermic removal of associated small papillary growths allowed
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Middlesex Hospital- Meyerstein Institute
London, United KingdomAbrir Middlesex Hospital- Meyerstein Institute en Google Maps