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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin-gemcitabine | Experimental | 3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive |
|
| cisplatin-gemcitabine | Active Comparator | 3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin-Gemcitabine Cisplatin-Gemcitabine | Drug | Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate | 6 months |
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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,
Exclusion Criteria:
• performance status 2-4 according to ECOG performance status scale.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AssiutU | Asyut | Egypt |
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Single blind study
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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