Back to resultsDosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Primary Purpose
Cervix Cancer
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
IMRT planning
4-Field Radiation Planning
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer focused on measuring Cervix Cancer, IMRT, Organ Motion, Target Definition
Eligibility 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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cervix Cancer
Arm Description
Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre
Outcomes
Primary Outcome Measures
Reduction in dose to organs at risk
Secondary Outcome Measures
Target Coverage
Full Information
NCT ID
NCT00981552
First Posted
September 21, 2009
Last Updated
September 21, 2009
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00981552
Brief Title
Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Official Title
Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer
Keywords
Cervix Cancer, IMRT, Organ Motion, Target Definition
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervix Cancer
Arm Type
Other
Arm Description
Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre
Intervention Type
Radiation
Intervention Name(s)
IMRT planning
Intervention Type
Radiation
Intervention Name(s)
4-Field Radiation Planning
Primary Outcome Measure Information:
Title
Reduction in dose to organs at risk
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target Coverage
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian Thomas, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
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