Long Term Results of the Canadian Breast IMRT Study

Breast Cancer Clinical Trial

— IMRT-FU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01803139
• Other study ID #: IMRT-02
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 1, 2012
• Last updated: March 1, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2013
• Source: Sunnybrook Health Sciences Centre
• Contact: Jean-Philippe Pignol, MD, PhD
• Phone: 416 480 4998
• Email: jean-philippe.pignol[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 358
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

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

Intervention

Device:
• Adjuvant breast radiotherapy
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Canada	Vancouver Island Cancer Centre	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic breast pain using Visual Analog Scale	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).	8 years plus or minus one year	No
Primary	Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0)	Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).	8 years plus or minus one year	No
Primary	Chronic breast pain using the prescription of pain killer	The use of pain killer will be recorded.	8 years plus or minus one year	No
Primary	Chronic breast pain using the McGill pain questionnaire	Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.	8 years plus or minus one year	No
Secondary	Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale	Skin and subcutaneous late radiation toxicity will be assessed by the clinical trial assistant using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer rating system for the cosmesis assessment. This scale evaluates skin discoloration and oedema comparing between breasts as no, small, moderate or large differences.	8 years plus or minus one year	No
Secondary	Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)	The patient's cosmesis self-report will be used as most reliable cosmetic endpoint and will use the Breast Cancer Treatment Outcome Scale (BCTOS).	8 years plus or minus one year	No
Secondary	Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30)	At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life general module (C-30) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.	8 years plus or minus one year	No
Secondary	Skin and sub-cutaneous delayed telangiectasia	Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2.	8 years plus or minus one year	No
Secondary	Skin and sub-cutaneous induration	Induration will be evaluated using the Late Radiation Morbidity Scoring Scheme scale that classifies fibrosis in four grades.	8 years plus or minus one year	No
Secondary	Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale	Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.	8 years plus or minus one year	No
Secondary	Cosmesis using digital photographs	Digital photographs will be taken of the treated and untreated breasts and will be evaluated for cosmetic results by four blinded individuals using the EORTC criteria and the consensus score will be recorded.	8 years plus or minus one year	No
Secondary	Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23)	At time of initial treatment patient's quality of life was assessed at baseline, the last week of treatment, and 6 weeks after treatment using the European Organization for Research and Treatment of Cancer (EORTC) quality of life breast module (BR-23) self-assessment questionnaire. The same questionnaire will be administered to ensure consistency in the quality of life assessment and enable comparisons over time for individuals and cohorts.	8 years plus or minus one year	No