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

January 18, 2011
January 18, 2011
January 2011
February 2016   (final data collection date for primary outcome measure)
Late Grade II-IV bowel toxicity [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Cancer Cervix
  • Radiation: Conventional Radiation
    Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks
  • 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
  • Active Comparator: Conventional RT
    Patients in this arm will receive conventional radiation with or without chemotherapy
    Intervention: Radiation: Conventional Radiation
  • Experimental: Tomotherapy based IGRT
    Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy
    Intervention: Radiation: Tomotherapy based IGRT
Chinnachamy AN, Chopra S, Krishnatry R, Kannan S, Thomas B, Mahantshetty U, Engineer R, Shrivastava SK. Evaluation of interobserver and interscale agreement in assessing late bowel toxicity after pelvic radiation in patients with carcinoma of the cervix. Jpn J Clin Oncol. 2013 May;43(5):508-14. doi: 10.1093/jjco/hyt028. Epub 2013 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
February 2018
February 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Supriya Chopra, MD, DNB 02227405000 ext 5510 schopra@actrec.gov.in
India
 
NCT01279135
Project 803
Yes
Dr. Supriya Chopra, Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Tata Memorial Centre
Tata Memorial Hospital
Not Provided
Principal Investigator: Supriya Chopra, MD,DNB Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre
Tata Memorial Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP