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


Phase 3
20 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT
trial

Exclusion Criteria:

- Patients declining participating to this study

- Patients unable to travel to the study site

- Patients deceased

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Chronic breast pain using Visual Analog Scale

Outcome Description:

Quantitatively patients will be asked if they have spontaneous breast pain in the treated breast during the last 6 months, and will be asked to rate its intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (extreme pain).

Outcome Time Frame:

8 years plus or minus one year

Safety Issue:

No

Principal Investigator

Jean-Philippe Pignol, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre

Authority:

Canada: Health Canada

Study ID:

IMRT-02

NCT ID:

NCT01803139

Start Date:

April 2013

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer radiotherapy IMRT
  • Breast Neoplasms

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