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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by Tata Memorial Hospital
Information provided by:
Tata Memorial Hospital Identifier:
First received: January 18, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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.

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Late Grade II-IV bowel toxicity

Secondary Outcome Measures:
  • To identify small bowel dose volume characteristics that predict for Grade II-IV late toxicity
  • To identify preoperative functional imaging features that predict for local recurrence
  • To compare quality of life between Tomotherapy vs conventional radiotherapy

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01279135

Contact: Supriya Chopra, MD, DNB 02227405000 ext 5510

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   
Sponsors and Collaborators
Tata Memorial Hospital
Principal Investigator: Supriya Chopra, MD,DNB Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Supriya Chopra, Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre Identifier: NCT01279135     History of Changes
Other Study ID Numbers: Project 803
Study First Received: January 18, 2011
Last Updated: January 18, 2011

Keywords provided by Tata Memorial Hospital:
IGRT,Postoperative, Cervix, Late toxicity, Bowel processed this record on May 24, 2017