Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Carboplatin; Cisplatin; Gemcitabine

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.