To study and compare two treatment modalities for locally advanced squamous cell cervical cancer - chemotherapy followed by surgery versus simultaneous chemoradiatio
Phase 3
- Conditions
- Health Condition 1: null- Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2 to IIB.
- Registration Number
- CTRI/2013/07/003815
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 730
Inclusion Criteria
1.Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB.
2.No evidence of visceral, skeletal or extra-abdominal nodal metastases.
3.Good performance status (Karnofsky performance score > 70)
4.Normal hematological & biochemical parameters including normal renal function
5.No prior treatment
Exclusion Criteria
1.Evidence of visceral, skeletal or extra-abdominal nodal metastases
2.Any prior treatment for cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival <br/ ><br>Overall Survival <br/ ><br>Timepoint: Progression Free Survival calculated from the date of entry into the study to the date of the first physical or radiographic evidence of disease relapse or death due to disease or the last follow up visit. Overall survival calculated from the date of entry into the study to the date of death due to any cause or the last follow up visit. The median progression free survival and median overall survival will be calculated in months by Kaplan-Meier curves.
- Secondary Outcome Measures
Name Time Method The rate of distant metastases in the two groups.Timepoint: None