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

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ClinicalTrials.gov Identifier: NCT01279135
Recruitment Status : Unknown
Verified January 2011 by Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Tata Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Cancer Cervix Radiation: Conventional Radiation Radiation: Tomotherapy based IGRT Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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.
Study Start Date : January 2011
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Late Grade II-IV bowel toxicity

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

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