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Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure

NCT04311580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-06-22

No results posted yet for this study

Summary

Patients with urothelial high risk non-muscle invasive bladder cancer patients will be treated with intravesical electromotive drug administration/mitomycin (EMDA/MMC) after bacillus Calmette-Guerin (BCG) failure. Patients are scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for non-responders and a followup 10 monthly treatments for responders. Complete response will be defined as histological disappearance of malignancy on bladder biopsy and resolution of abnormal cytological findings after treatment. Time to first recurrence, time to progression, overall survival, and disease-specific survival wil be estimated by use of the Kaplan-Meier method.

Conditions

Interventions

COMBINATION_PRODUCT

intravesical electromotive administration of mitomycin

Sponsors & Collaborators

  • University of Bari

    collaborator OTHER

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • SAVINO M DI STASI · TOR VERGATA UNIVERSITY OF ROME

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-01
Primary Completion
2013-12-31
Completion
2020-03-10

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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 NCT04311580 on ClinicalTrials.gov