Trial record 1 of 1 for:    NCT01803139
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Long Term Results of the Canadian Breast IMRT Study (IMRT-FU)

This study is not yet open for participant recruitment.
Verified March 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01803139
First received: March 1, 2012
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Device: Adjuvant breast radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Chronic breast pain using Visual Analog Scale [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    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).

  • Chronic breast pain using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    Quantitatively pain intensity will be evaluated using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).

  • Chronic breast pain using the prescription of pain killer [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    The use of pain killer will be recorded.

  • Chronic breast pain using the McGill pain questionnaire [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.


Secondary Outcome Measures:
  • Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    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.

  • Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    The patient's cosmesis self-report will be used as most reliable cosmetic endpoint and will use the Breast Cancer Treatment Outcome Scale (BCTOS).

  • Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) general module questionnaire (C-30) [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    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.

  • Skin and sub-cutaneous delayed telangiectasia [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2.

  • Skin and sub-cutaneous induration [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    Induration will be evaluated using the Late Radiation Morbidity Scoring Scheme scale that classifies fibrosis in four grades.

  • Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis.

  • Cosmesis using digital photographs [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    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.

  • Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23) [ Time Frame: 8 years plus or minus one year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 358
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard breast radiotherapy
The treatment is planned using 2D wedges optimisation on the central CT-planning slice.
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.
Other Name: Intensity Modulated Radiation Therapy
Experimental: Breast IMRT
The treatment is planned 3D IMRT optimisation using all CT-planning slices.
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.
Other Name: Intensity Modulated Radiation Therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803139

Contacts
Contact: Jean-Philippe Pignol, MD, PhD 416 480 4998 jean-philippe.pignol@sunnybrook.ca
Contact: Pauline Truong, MD, MSc ptruong@bccancer.bc.ca

Locations
Canada, British Columbia
Vancouver Island Cancer Centre Not yet recruiting
Victoria, British Columbia, Canada, V8R6V5
Contact: Pauline Truong, MD, MSc       ptruong@bccancer.bc.ca   
Contact: Michael Miller       MMiller2@bccancer.bc.ca   
Principal Investigator: Pauline Truong, MD, MSc         
Sub-Investigator: Ivo A Olivotto, MD         
Canada, Ontario
Sunnybrook Odette Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Jean-Philippe Pignol, MD, PhD    416 480 4998    jean-philippe.pignol@sunnybrook.ca   
Sub-Investigator: Eileen Rakovitch, MD, MSc         
Principal Investigator: Jean-Philippe Pignol, MD, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
Investigators
Principal Investigator: Jean-Philippe Pignol, MD, PhD Sunnybrook Health Sciences Centre
  More Information

Publications:
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01803139     History of Changes
Other Study ID Numbers: IMRT-02
Study First Received: March 1, 2012
Last Updated: March 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Breast cancer radiotherapy IMRT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014