A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)

INTRODUCTION

  • Org Study ID: Version 4 Date: 04.08.2016
  • Secondary ID: N/A
  • NTC ID: NCT02695771
  • Sponsor: Spectrum Health Hospitals

BRIEF SUMMARY

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

DETAILED DESCRIPTION

This study will compare standard of care treatment for patients with non-muscle invasive bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C, Gemcitabine or no additional treatment immediately following TURBT in the operating suite. All treatment, surgical procedures and follow up care will be conducted according to standard of care treatment.

  • Overall Status
    Unknown status
  • Start Date
    April 2016
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Efficacy will be measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study treatment, graded according to NCI CTCAE Version 4.03

Primary Outcome 1 - Timeframe: Two years

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
sign an informed consent for the study

- be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.
Exclusion Criteria:
patients unable to consent for themselves

- individuals under 18 years old

- pregnant women

- prisoners

- patients with known allergy or intolerance to the mitomycin C or Gemcitabine

- any other sound medical, psychiatric and/or social reason as determined by the investigator.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: John E Humphrey, MD

Role: Principal Investigator

Affiliation: Spectrum Health Hospitals

Overall Contact

Name: John E Humphrey, MD

Phone: 616-267-8406, 616-267-8406

Email: susan.engerman@spectrumhealth.org, pamela.carlon@spectrumhealth.org

LOCATION

Facility Status Contact
Facility: Spectrum Health Medical Group-Division of Urology-LHCP
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Susan M Engerman, BSN
616-267-8406
susan.engerman@spectrumhealth.org
Facility: Spectrum Health Medical Group-Division of Urology
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Pamela Carlon, RN
616-267-8406
pamela.carlon@spectrumhealth.org
Facility: Urologic Consultants P.C.
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Susan M Engerman, BSN
616-267-8406
susan.engerman@spectrumhealth.org