Role of chemotherapy in high grade urinary bladder tumour
Phase 4
- Conditions
- Health Condition 1: null- CARCINOMA BLADDER
- Registration Number
- CTRI/2016/09/007241
- Lead Sponsor
- KING GEORGE MEDICAL UNIVERSITY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1.Performance Status (Eastern Cooperative Oncology Group - ECOG) 0 â?? 2
2.Histologically confirmed muscle-invasive bladder cancer
3.Resectable disease at diagnosis (clinical stages T2 - T4a, N0 - 1, M0) transitional cell carcinoma of the bladder
4.Patients should have adequate bone marrow function (white blood cell count > 3.0 x 109/L, platelet count > 150 x 109/L)
5.Renal function (serum creatinine < 2.0 mg/dL)
Exclusion Criteria
1.No history of previous chemotherapy or radiotherapy.
2.Patients with previous history of other cancers
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the radiological and pathological response rateTimepoint: 6 MONTHS
- Secondary Outcome Measures
Name Time Method 1. Tolerability of the regimen <br/ ><br>2.Intra-operative and post-operative outcome of definitive surgery (radical cystectomy) after GC regimen. <br/ ><br>Timepoint: 6 MONTHS