MedTrace Logo

Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

NCT05671900 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-08

No results posted yet for this study

Summary

Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Conditions

  • Non-muscle-invasive Bladder Cancer

Interventions

DRUG

Gemcitabine 1000 mg, Docetaxel 37.5g

6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    lead OTHER

Principal Investigators

  • Mirko Bakula · UHC Zagreb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Croatia

Study Locations

More Related Trials

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 NCT05671900 on ClinicalTrials.gov