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Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer

NCT02948543 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2023-06-18

No results posted yet for this study

Summary

Open label, randomised phase 3 trial of the addition of Mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to compare disease-free survival between treatment arms: BCG alone versus Mitomycin in addition to BCG.

Conditions

Interventions

BIOLOGICAL

Bacillus of Calmette-Guerin (BCG)

A strain of tubercle bacillus which modifies biologic response.

DRUG

Mitomycin (MM)

An antibiotic produced by a soil actinomycete which inhibits DNA synthesis.

Sponsors & Collaborators

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    collaborator OTHER

  • Cancer Australia

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Dickon Hayne · Fiona Stanley Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02948543 on ClinicalTrials.gov