Urinary Bladder Cancer
Conditions
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
Interventions
DRUGCarboplatin-Gemcitabine Cisplatin-Gemcitabine
Carboplatin-gemcitabine versus cisplatin-gemcitabine as neoadjuvant chemotherapy for treatment of muscle invasive urinary bladder cancer
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate | 6 months |
Countries
Egypt
Outcome results
None listed