Health Condition 1: null- Cervical cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 to 65 years 2. Histopathological diagnosis of carcinoma cervix with post operative intermediate or high risk feature 3. Planned for Wertheimâ??s hysterectomy or has already undergone Wertheimâ??s hysterectomy or has undergone simple hysterectomy with no evidence of residual nodes on MRI PET imaging+/- confirmatory nodal biopsy 4. No evidence of para aortic nodal metastasis
Exclusion criteria
Exclusion criteria: 1. History of multiple previous abdominal surgery placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder 2. Rectal polyps or extensive hemorrhoids
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| o To identify small bowel dose volume characteristics that predict for grade II to grade IV late toxicity o To identify preoperative imaging features that predict for local and distance recurrence following recurrence following pelvic radiotherapy (+/- chemotherapy) o To compare QOL score between conventional RT and IG-IMRT. Timepoint: 2-3 years of complete accrual | — |
Primary
| Measure | Time frame |
|---|---|
| To compare late small bowel grade II-IV toxicity of Tomotherapy based pelvic IG-IMRT and Conventional Pelvic RTTimepoint: final analysis : 7 years from continuation of trial. Interim analysis: when median follow-up of 50% of patients reaches 18 months. | — |
Countries
India
Contacts
Tata memorial Centre ACTREC