High dose radiotherapy in the treatment of advanced carcinoma cervix -a prospective study
Phase 2
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2023/07/055597
- Lead Sponsor
- Dr Anjan Bera
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age- 30 to 70 years
Histologically confirmed non-metastatic loco-regionally advanced carcinoma of the cervix (FIGO Stage- IIB-IVA
Adequate hematological functions
Adequate hepatic, renal function, and cardiac evaluation
ECOG performance status 0-3
Participants can understand and sign informed Consent for the study
Exclusion Criteria
Any medical condition that precludes delivery of Radiation Therapy/ Concurrent Chemotherapy
Metastatic Cervical carcinoma
Patients unable to answer or unable to provide subjective information.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sample size as calculated could be recruited, <br/ ><br>Better tumor response, disease free survival, better overall survival <br/ ><br>Reasonably low levels of treatment-related toxicities.Timepoint: To evaluate the tumor response at 12 weeks after completion treatment, then 4 monthly and last follow up.
- Secondary Outcome Measures
Name Time Method To evaluate the radiotherapy-related acute & late toxicities in these patients.Timepoint: 2 years