Shorter course of radiation therapy for carcinoma of the uterine cervix using advance radiotherapy technology
Phase 2
- Conditions
- Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri
- Registration Number
- CTRI/2023/08/056093
- Lead Sponsor
- Dr Ram Manohar Lohia Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Histologically proven squamous carcinoma of the uterine cervix of FIGO stage IB2-IIIC1(FIGO-2018)
Patient being treated definitively with radiotherapy with or without concurrent chemotherapy.
Patient willing to sign the informed consent
Karnofsky Performance Status > 70
Normal complete blood counts, kidney and liver function tests
No prior chemotherapy or radiotherapy and surgery
Exclusion Criteria
Stage other than IB2-IIIC1(FIGO2018)
Patients who have received neoadjuvant chemotherapy.
Any histopathology other than squamous cell carcinoma
Synchronous or metachronous malignancy
Pregnant or lactating women
Uncontrolled concurrent illness like diabetes mellitus and hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the acute toxicity in patients of locally advanced cervical carcinoma treated with hypo fractionated intensity modulated radiotherapy followed by high dose rate brachytherapyTimepoint: Weekly during treatment, monthly for the first 3 months, then 2 monthly for the next 6 months & then 3 monthly until 2 year after treatment.
- Secondary Outcome Measures
Name Time Method To assess the late toxicity & early clinical outcome in terms of loco-regional control at six months for this regimen <br/ ><br>Timepoint: 2 years from the completion of treatment