Chemotherapy followed by radiotherapy response assessment in muscle invasive urinary bladder carcinoma
Phase 2
Completed
- Conditions
- Health Condition 1: null- healthy
- Registration Number
- CTRI/2017/08/009318
- Lead Sponsor
- ONE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Muscle invasive bladder carcinoma,
2. Stage T2-T4, N0- N1,M0according to AJCC 2010 Staging.
3. Karnofsky Performance Status scale(KPS) >70.
4. All patients were explained about the protocol and a written informed consent was obtained.
Exclusion Criteria
1. Non muscle invasive bladder carcinoma / Metastatic disease.
2. KPS <70
3. Significant comorbid conditions like Hypertension, Diabetes Mellitus, Coronary artery disease for more than 5 years.
4. Any other primary malignancy
5. Abnormal Haemogram: a. Haemoglobin < 10gm/dl, b. Platelet count < 100000/ cmm, c. Total leucocyte count < 3000/cmm.
6. Abnormal renal function test: a. Blood urea >50mg/dl, b. Serum creatinine >1.2mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the response rate after neoadjuvant chemotherapy. <br/ ><br>2.To assess the response rate after radical radiation therapy. <br/ ><br>Timepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method .To evaluate treatment related toxicitiesTimepoint: 3 months