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Sequential Combination Therapy in Bladder Cancer

NCT03790384 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-12-31

No results posted yet for this study

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 .

Conditions

Interventions

DRUG

Mitomycin

Patients receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG) with a 40 mg mitomycin instillation the day before .

Sponsors & Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Principal Investigators

  • Andrea Tubaro · Azienda Ospedaliera "Sant'Andrea"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2019-09-15
Completion
2021-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790384 on ClinicalTrials.gov