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

NCT05822934 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: Urinary bladder cancer
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical response rate

  6 months

Study Arms (2)

Carboplatin-gemcitabine

EXPERIMENTAL

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

Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine

cisplatin-gemcitabine

ACTIVE COMPARATOR

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

Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine

Interventions

Carboplatin-Gemcitabine Cisplatin-Gemcitabine DRUG

Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer

Carboplatin-gemcitabine; cisplatin-gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

AssiutU

Asyut, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor principal investigator

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: April 21, 2023
• Study Start: November 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)