Trial Information
Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.
Inclusion Criteria:
- Histopathological diagnosis of carcinoma cervix with postoperative intermediate or
high risk features.
- Age >18 years.
- Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy
OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET
imaging+/- confirmatory nodal biopsy.
- No evidence of paraaortic nodal metastasis.
Exclusion Criteria:
- 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.
- Rectal Polyps or extensive hemorrhoids.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Late Grade II-IV bowel toxicity
Safety Issue:
No
Principal Investigator
Supriya Chopra, MD,DNB
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre
Authority:
Data AND Safety Monitoring Committee, Tata Memorial Centre, Mumbai: India
Study ID:
Project 803
NCT ID:
NCT01279135
Start Date:
January 2011
Completion Date:
February 2018
Related Keywords:
- Cancer Cervix
- IGRT,Postoperative, Cervix, Late toxicity, Bowel