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

Early Phase 1

Completed

• Conditions: Cervix Cancer
• Interventions: Radiation: IMRT planning; Radiation: 4-Field Radiation Planning

• Registration Number: NCT00981552
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2009-07
• Status Verified: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Last Update Submitted: 2009-09-21
• Study First Posted: 2009-09-22
• Last Update Posted: 2009-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cervix Cancer	IMRT planning	Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre
Cervix Cancer	4-Field Radiation Planning	Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre

Primary Outcome Measures

Name	Time	Method
Reduction in dose to organs at risk	6 months

Secondary Outcome Measures

Name	Time	Method
Target Coverage	6 months

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada