Long Term Results of the Canadian Breast IMRT Study — IMRT-FU  

Breast Cancer Clinical Trial

Official title: Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

Status Not yet recruiting

Clinical Trial Summary

Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.

Clinical Trial Description

In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy.

The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT01803139
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Contact: Jean-Philippe Pignol, MD, PhD
• Phone: 416 480 4998
• Email: jean-philippe.pignol@sunnybrook.ca
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2013
• Completion date: June 2014