Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the frequency of chronic breast pain about 8 years after the delivery of the radiation treatment, and to compare the frequency between subjects that received breast Intensity-Modulated Radiation Therapy (IMRT) and those that received standard wedge radiotherapy. The cosmetic result, meaning how similar is the treated breast compared to the non-treated breast, will be assessed. Also, the occurrence of delayed radiation treatment side effects including tiny red vessels in the skin, breast indurations (hardening of the skin), skin discoloration, oedema (swelling of the breast), and skin dryness will be captured.

Detailed Description
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The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique. The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study Exclusion Criteria: Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY|LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy. | A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire | 8 years post RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does breast IMRT reduce the occurrence of late radiation therapy side effects | A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire | 8 years post RT | 
| Does breast IMRT effect long term QOL | A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire | 8 Years post RT | 
| Does IMRT effect local recurrence rates, overall and disease free survivals. | Data collection of local recurrences, overall and disease free survivals. | 8 years post RT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BREAST IRRADIATION USING INTENSITY MODULATED RADIATION THERAPY