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Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial


Inclusion Criteria:



- Age 18 years or older

- Patients must have pathologically confirmed non-muscle invasive urothelial bladder
carcinoma by the Department of Pathology New York Presbyterian Hospital, Weill
Medical College of Cornell University or Memorial Sloan Kettering Cancer Center or a
documented past history of Ta or T1 non-muscle invasive urothelial bladder tumors.

- Intermediate Risk UBC patients: Recurrence Total Score = 1 to 9

Exclusion Criteria:

- Any intravesical therapy within the past six months prior to current diagnosis

- Currently being treated or scheduled to have radiation treatment for bladder cancer
during the study

- Scheduled to have surgery for bladder cancer during the study

- Currently being treated or scheduled to have treatment with any chemotherapeutic
agent during the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test non-inferiority of intravesical chemo using optimized dose of MMC to intravesical BCG immunotherapy in the prevention of bladder cancer recurrence at 2 years among non-muscle-invasive UBC patients.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Guido Dalbagni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-118

NCT ID:

NCT00974818

Start Date:

September 2009

Completion Date:

March 2012

Related Keywords:

  • Bladder Cancer
  • Bladder
  • Mitomycin C
  • MMC
  • TheracysR Bacillus Calmette-Guerin
  • BCG
  • intravesical
  • 09-118
  • Urinary Bladder Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Weill Medical College of Cornell University New York, New York  10021