Radiation therapy with Image Guided Intensity Modulated Radiotherapy and standard radiation therapy after surgery in cervical cancer patients.
Phase 3
- Registration Number
- CTRI/2010/091/002959
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
1.Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features.
2.Age > 18 years
3.Planned for Wertheim's hysterectomy or has already undergone simple hysterectomy and has no evidence of residual pelvic nodes on MRI/PET imaging +/_ confirmatory nodal biopsy.
4.No evidence of paraaortic nodal biopsy.
5.WIlling for specimen archiving in tumor tissue biorepository.
Exclusion Criteria
1.History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder.
2.Rectal Polyps or extensive hemorroids causing bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate Small Bowel ToxicityTimepoint: Not Available
- Secondary Outcome Measures
Name Time Method 1. Dose Volume Histogram correlates of late small bowel toxicity.<br>2. Preoperative translational imaging (multifunctional PET MRI) correlates of local and distant control.<br>3.Comparative Quality of LifeTimepoint: Not Applicable