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Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00981552
First received: September 21, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.


Condition Intervention Phase
Cervix Cancer
 Radiation: IMRT planning
Radiation: 4-Field Radiation Planning
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Reduction in dose to organs at risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target Coverage [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cervix Cancer
Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre
 Radiation: IMRT planning Radiation: 4-Field Radiation Planning

Detailed Description:

Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre

Exclusion Criteria:

  • no imaging and no anatomical description of disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981552

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Gillian Thomas, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr Gillian Thomas, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00981552     History of Changes
Other Study ID Numbers: IMRTCC
Study First Received: September 21, 2009
Last Updated: September 21, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Cervix Cancer
IMRT
Organ Motion
Target Definition

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013