Investigation on the role of ultra fractioned low dose radiation and chemotherapy in lower part (neck) of the womb
Phase 2
Completed
- Conditions
- Health Condition 1: null- Women with histologically proven diagnosis of squamous cell carcinoma cervix FIGO stage IIB to IIIB will be included in the study.
- Registration Number
- CTRI/2012/01/002358
- Lead Sponsor
- Fluid Research Grant CMC Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
a.Inclusion Criteria:
Women with histologically proven diagnosis of squamous cell carcinoma cervix FIGO stage IIB to IIIB will be included in the study. Inclusion criteria
1.Age less than or equal to 70 years
2.ECOG less than or equal to 2
3.Pretreatment Hb more than 9 gm%
4.Leucocytes more than or equal to 4000 / mm3
5.Platelets more than or equal to 1,00,000/mm3
6.Normal hepatic and renal parameters
Exclusion Criteria
Patients with renal, hepatic or cardiac co-morbidities or previous history of chemotherapy/radiation therapy/malignancy will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess safety of using neoadjuvant chemotherapy with low dose radiation in locally advanced Squamous cell carcinoma of cervixTimepoint: during the phase of treatment
- Secondary Outcome Measures
Name Time Method To assess efficacy of Neoadjuvant chemotherapy in combination with low dose radiotherapy in locally advanced Squamous cell carcinoma of cervix in terms of local control and overall survival at 1 yearTimepoint: 1 year