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

NCT ID: NCT05822934

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-30

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

Conditions

Urinary Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Carboplatin-gemcitabine

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

Group Type: EXPERIMENTAL

Carboplatin-Gemcitabine Cisplatin-Gemcitabine

Intervention Type: DRUG

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

cisplatin-gemcitabine

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

Group Type: ACTIVE_COMPARATOR

Carboplatin-Gemcitabine Cisplatin-Gemcitabine

Intervention Type: DRUG

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

Interventions

Carboplatin-Gemcitabine Cisplatin-Gemcitabine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Mahmoud Moustafa Abdelakher

Doctor principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AssiutU

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Urinary bladder cancer

Identifier Type: -

Identifier Source: org_study_id