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

Primary Purpose

Non-muscle-invasive Bladder Cancer

Status
Active
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Gemcitabine 1000 mg, Docetaxel 37.5g
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-muscle-invasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: BCG-naive patients with high-risk non-muscle invasive bladder cancer Exclusion Criteria: patients in whome cystectomy is planned

Sites / Locations

  • University Hospital Centre Zagreb

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

All patients receive same intervention throughout the trial.

Outcomes

Primary Outcome Measures

Reccurence free survival
Patients with no bladder cancer reccurence during therapy

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
May 15, 2023
Sponsor
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05671900
Brief Title
Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer
Official Title
The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle-invasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
All patients receive same intervention throughout the trial.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine 1000 mg, Docetaxel 37.5g
Other Intervention Name(s)
Sequential intravesical chemotherapy GEM/DOCE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reccurence free survival
Description
Patients with no bladder cancer reccurence during therapy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BCG-naive patients with high-risk non-muscle invasive bladder cancer Exclusion Criteria: patients in whome cystectomy is planned
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirko Bakula
Organizational Affiliation
UHC Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Protocol, patients' medical information and results will be shared

Learn more about this trial

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

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