A clinical trial to compare toxicity reduction between image guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy in Cancer Cervix (PARCER) patients.
Phase 3
- Conditions
- Health Condition 1: null- Cervical cancer
- Registration Number
- CTRI/2012/12/003249
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 240
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>Interim analysis: when median follow-up of 50% of patients reaches 18 months.
- Secondary Outcome Measures
Name Time Method oTo identify small bowel dose volume characteristics that predict for grade II to grade IV late toxicity <br/ ><br>oTo identify preoperative imaging features that predict for local and distance recurrence following recurrence following pelvic radiotherapy (+/- chemotherapy) <br/ ><br>oTo compare QOL score between conventional RT and IG-IMRT. <br/ ><br>Timepoint: 2-3 years of complete accrual