Study Comparing Intensive Radiotherapy Versus Conventional ChemoRadiotherapy In Cervical Cancer
Phase 2
- Conditions
- Health Condition 1: null- Locally Advanced Cervical Cancer.
- Registration Number
- CTRI/2018/04/013215
- Lead Sponsor
- Dr Debashis Das
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 35 -60yrs 2. No history of Pelvicoperation 3. Pathologically proved carcinoma cervix (FIGO stage 2B to 4A)4.Patient signed consent forms.5. No prior history of malignancy. 6.Karnofsky Performance Status (KPS) >= 70. 7. No prior history of exposure tocytotoxic chemotherapy or radiation. 8. No clinical or radiological evidenceof metastasis at presentation. 9. Adequate bone marrow function: Hb > 10g/dl; WBC > 4000/mm3 (ANC >= 2000/mm3); Platelets >= 1,00,000/mm3.
Exclusion Criteria
1. Age >=60 2. Pregnancy 3. History of Pelvicoperation 4. Stage 4B disease . 5. Karnofsky Performance Status (KPS) <70. 6. Participation in any other study on cancer cervix. 7. Prior pelvic radiation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess and compare the response and safety of true accelerated radiation alone with reduced overall treatment duration to conventional concomitant chemoradiation in locally advanced carcinoma cervix .Timepoint: One Year and Six Months
- Secondary Outcome Measures
Name Time Method a. Assessment of response b. Detection of recurrence, if any c. Assessment of quality of life d. Assessment of toxicity(acute & late).Timepoint: One Year and Six Months