Know Cancer

or
forgot password

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.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cancer Cervix

Thank you

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

Name

Location