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

Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981552
• Other study ID #: IMRTCC
• Status: Completed
• Phase: Phase 0
• First received: September 21, 2009
• Last updated: September 21, 2009
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• IMRT planning

• 4-Field Radiation Planning

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in dose to organs at risk		6 months	No
Secondary	Target Coverage		6 months	No