Sequential Combination Therapy in Bladder Cancer

• Status: Unknown status
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: Male

Summary

A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres. The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after Trans-Urethral Resection of the Bladder (TURB) and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included. Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with Immucyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Azienda Ospedaliera "Sant'Andrea"
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Patients with high risk non muscle invasive bladder cancer

• High risk of progression (EORTC risk score > 6)

• Males

• Signature of Informed Consent

• Ability of consent

Exclusion Criteria:

• Low Risk Non-Muscle Invasive Bladder Cancer

• Muscle Invasive Bladder Cancer

• Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract

• Previous bladder or prostate surgery

• Prostate or bladder radiotherapy

• Urinary tract infection

• Chronic urinary retention or indwelling catheters

• Neurological patients

• Previous BCG infections

• Previous or current chemotherapy for other kind of cancers

• Patients older than 75

• WHO performance status 3-4

• Residual tumour on re-TURB