Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors
valrubicin
+ conventional surgery
Enfermedades Urogenitales+6
+ Enfermedades de la vejiga urinaria
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1996
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder. II. Assess the toxicity of AD 32 in these patients. OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone. Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes. Arm II: Patients undergo only surgery to remove bladder tumors. Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically diagnosed stage 0 (Ta), stage I, or recurrent superficial transitional cell carcinoma of the bladder Must have at least 2 papillary appearing bladder tumors by cystoscopic examination Patients with recurrent disease must have no history of Tis tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifiers for bladder cancer Chemotherapy: No prior or concurrent chemotherapy for bladder cancer No prior AD 32 therapy for bladder cancer Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy Surgery: At least 9 months since any complete transurethral resection of the bladder
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 53 ubicaciones
Urology Associates, Ltd.
Phoenix, United StatesUniversity of California San Diego Cancer Center
La Jolla, United StatesSan Diego Urology Center
La Mesa, United States