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Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer

Primary Purpose

Urinary Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Carboplatin-Gemcitabine Cisplatin-Gemcitabine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Cancer

Eligibility Criteria

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

Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are • Age above 18 years, Pathologically proven urinary bladder cancer, Patients with clinical stages T2-4a N0-3 M0, Patients with good renal and liver functions patients with no distant metastases, no other malignancy (double malignancy). Performance status 0-1 according to ECOG performance status scale. Patients with no contraindications for radiotherapy. Exclusion Criteria: • performance status 2-4 according to ECOG performance status scale. patients refuse to receive chemotherapy, patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia, patients with M1 disease.

Sites / Locations

  • AssiutURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carboplatin-gemcitabine

cisplatin-gemcitabine

Arm Description

3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive

3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive

Outcomes

Primary Outcome Measures

Clinical response rate

Secondary Outcome Measures

Full Information

First Posted
January 24, 2023
Last Updated
April 22, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05822934
Brief Title
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
Official Title
Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

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
Yes

5. Study Description

Brief Summary
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy
Detailed Description
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy. After finishing treatment, all patients should undergo follow up every 3 months for two years then six monthly thereafter .Follow up will include History, physical examination, full laboratory works (CBC, renal function testing and liver function testing). Imaging by CT or MRI abdomen and pelvis for all patients and cystoscopy in bladder preservation protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind study
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin-gemcitabine
Arm Type
Experimental
Arm Description
3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
Arm Title
cisplatin-gemcitabine
Arm Type
Active Comparator
Arm Description
3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
Intervention Type
Drug
Intervention Name(s)
Carboplatin-Gemcitabine Cisplatin-Gemcitabine
Intervention Description
Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer
Primary Outcome Measure Information:
Title
Clinical response rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are • Age above 18 years, Pathologically proven urinary bladder cancer, Patients with clinical stages T2-4a N0-3 M0, Patients with good renal and liver functions patients with no distant metastases, no other malignancy (double malignancy). Performance status 0-1 according to ECOG performance status scale. Patients with no contraindications for radiotherapy. Exclusion Criteria: • performance status 2-4 according to ECOG performance status scale. patients refuse to receive chemotherapy, patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia, patients with M1 disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelakher
Phone
00201066863965
Email
ahmed.oncology@yahoo.com
Facility Information:
Facility Name
AssiutU
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelakher
Phone
00201066863965

12. IPD Sharing Statement

Learn more about this trial

Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer

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