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Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix (PARCER)

This study is currently recruiting participants.
Verified January 2011 by Tata Memorial Hospital
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01279135
First received: January 18, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.


Condition Intervention Phase
Cancer Cervix
 Radiation: Conventional Radiation
Radiation: Tomotherapy based IGRT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Late Grade II-IV bowel toxicity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify small bowel dose volume characteristics that predict for Grade II-IV late toxicity [ Designated as safety issue: No ]
  • To identify preoperative functional imaging features that predict for local recurrence [ Designated as safety issue: No ]
  • To compare quality of life between Tomotherapy vs conventional radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2011
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional RT
Patients in this arm will receive conventional radiation with or without chemotherapy
 Radiation: Conventional Radiation
Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks
Experimental: Tomotherapy based IGRT
Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy
 Radiation: Tomotherapy based IGRT
Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279135

Contacts
Contact: Supriya Chopra, MD, DNB 02227405000 ext 5510 schopra@actrec.gov.in

Locations
India
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre Recruiting
Navi Mumbai, Maharashtra, India, 410210
Contact: Supriya Chopra, MD,DNB     022-27405000 ext 5510     schopra@actrec.gov.in    
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Supriya Chopra, MD,DNB Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre
  More Information

No publications provided by Tata Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Supriya Chopra, Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT01279135     History of Changes
Other Study ID Numbers: Project 803
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Data AND Safety Monitoring Committee, Tata Memorial Centre, Mumbai: India

Keywords provided by Tata Memorial Hospital:
IGRT,Postoperative, Cervix, Late toxicity, Bowel

ClinicalTrials.gov processed this record on June 17, 2013