A study to assess the effect of two chemotherapy drugs (paclitaxel and Cisplatin) along with radiation in treating cancer of the uterine cervix
Phase 2
Completed
- Registration Number
- CTRI/2008/091/000029
- Lead Sponsor
- Department of Radiation Oncology Unit I, Christian Medical College, Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
? Women with previously untreated squamous cell carcinoma of cervix , stages IB2 ? III B
? Performance score ECOG 0, 1, 2
Exclusion Criteria
? Previous treatment for carcinoma cervix
? Hepatic/renal dysfunction
? Cardiac co morbidities (active cardiac disease like MI in the last 6 months, uncontrolled arrhythmias, Left ventricular dysfunction, cardiac failure)
? Pre existing Peripheral neuropathy
? Age > 70 years and < 18 years
? Para aortic lymph node involvement
? Pregnant women
? Synchronous malignancies
? S. creatinine >1.4, Creatinine clearance <50
? SGOT, SGPT and ALP > x 2.5 normal
? Hb<8.0g/dl, TC <3000/cmm, ANC <1000 /cmm, platelet count <1,00,000/cmm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method