Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous adeno or adenosquamous carcinoma FIGO stages IB3 to IVA Planned for curative chemoRT including MRI or TRUS based IGABT ECOG 0 1 and 2 Adequate organ function
Exclusion criteria
Exclusion criteria: Prior pelvic RT or chemotherapy Distant metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free SurvivalTimepoint: 2 year Progression free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival (OS), defined as time from randomization to death from any cause 3-year local control (LC), defined as absence of local recurrence 3-year distant metastasis-free survival (DMFS) Acute hematologic toxicity, assessed weekly during treatment and up to 90 days post-treatment using CTCAE v5.0 Late toxicity, assessed beyond 90 days post-treatment Quality of life (QoL) assessed at baseline, end of treatment, 3 months, 6 months, 1 year, and 2 years using EORTC QLQ-C30 and CX24 Tumor regression analysis, defined as change in tumor size between simulation and brachytherapy, and its correlation with clinical outcomes Timepoint: 3 year OS, 3 year local control 3 year Distant metastases free survival Acute toxicity - within 90 days of starting treatment Chronic toxicity - after 90 days of treatment QOL - at baseline, end of treatment, 3months, 6 months, 1year, 2 years tumor regression analysis at the time of diagnosis and at the time of brachytherapy | — |
Countries
India
Contacts
TAMILNADU GOVERNMENT MULTI SUPER SPECIALITY HOSPITAL, OMANDURAR