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Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

NCT00384891 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2014-10-07

No results posted yet for this study

Summary

The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer:

1. A combination of bladder wall heating and local chemotherapy (Synergo)
2. Bacillus Calmette-Guérin (BCG)

Conditions

  • Urinary Bladder Diseases
  • Urinary Bladder Neoplasms
  • Urinary Bladder Cancer
  • Malignant Tumor of Urinary Bladder
  • Urologic Diseases
  • Urologic Neoplasms
  • Neoplasms
  • Neoplasms by Site

Interventions

DEVICE

Synergo + MMC

Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C

DRUG

Bacillus Calmette-Guérin

Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Sponsors & Collaborators

  • Medical Enterprises Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Alfred A Witjes, MD PhD · Department of Urology, Radboud University Hospital, Nijmegen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Austria
  • Israel
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT00384891 on ClinicalTrials.gov