A Study Where twice weekly radiotherapy will be given internally during external beam radiotherapy treatment to see the feasibility toxicity and efficacy in locally advanced cervical cancer
Phase 2
- Conditions
- Health Condition 1: - Health Condition 2: C538- Malignant neoplasm of overlappingsites of cervix uteri
- Registration Number
- CTRI/2019/10/021486
- Lead Sponsor
- RADIOTHERAPY DEPARTMENT SSKM HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Age: 18 to 65 years.
2)Histology proven squamous cell carcinoma of cervix.
3)Patients with stage IIB
4)ECOG performance status 0 to 2
5)No previous history of treatment of cancer.
6)Creatinine clearance more than or equal to 60 ml/min
7)Patients must sign a study specific informed consent prior to study entry.
Exclusion Criteria
1)Evidence of distant metastases by clinical or radiological examination.
2)Previous history of treatment of pelvic malignancies.
3)Previous history of pelvic irradiation.
4)Other primary malignancy.
5)Significant co-morbidities that would not allow or would require modification of treatment of the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: <br/ ><br>To assess the acute toxicity according to the Radiation Therapy Oncology Group [RTOG] criteria. <br/ ><br>To assess the response rate in terms of complete response, partial response, stable disease and progressive disease (RECIST criteria, version 1.1) after 6 weeks from the completion of treatment. <br/ ><br>Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method Secondary endpoints: <br/ ><br>a)To assess the disease free survival (DFS) and time to progression (TTP) after treatment in patients having CR. <br/ ><br>Timepoint: 3 months