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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Urinary Bladder Cancer

Intervention / Treatment
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* Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin-gemcitabine<br>3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive | Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine<br>* Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer<br>|
| Active Comparator: cisplatin-gemcitabine<br>3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive | Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine<br>* Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate |  | 6 months |