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

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ClinicalTrials.gov Identifier: NCT00981552
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : September 22, 2009
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Cervix Cancer Radiation: IMRT planning Radiation: 4-Field Radiation Planning Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Study Start Date : December 2008
Primary Completion Date : July 2009
Study Completion Date : September 2009

Arm Intervention/treatment
Cervix Cancer
Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre
Radiation: IMRT planning Radiation: 4-Field Radiation Planning

Primary Outcome Measures :
  1. Reduction in dose to organs at risk [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Target Coverage [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00981552

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

Responsible Party: Dr Gillian Thomas, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00981552     History of Changes
Other Study ID Numbers: IMRTCC
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009

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

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