Breast Cancer
Conditions
Keywords
Breast cancer radiotherapy IMRT
Brief 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.
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.
Interventions
Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
Sponsors
British Columbia Cancer Agency
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic breast pain using Visual Analog Scale | 8 years plus or minus one year | 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) | 8 years plus or minus one year | 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 | 8 years plus or minus one year | The use of pain killer will be recorded. |
| Chronic breast pain using the McGill pain questionnaire | 8 years plus or minus one year | Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin and sub-cutaneous induration | 8 years plus or minus one year | 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 | 8 years plus or minus one year | Research assistant will use the four point scale European Organization for Research and Treatment of Cancer (EORTC) to evaluate cosmesis. |
| Skin and sub-cutaneous delayed side effects using the European Organization for Research and Treatment of Cancer (EORTC) scale | 8 years plus or minus one year | 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. |
| Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) breast module questionnaire (BR-23) | 8 years plus or minus one year | 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. |
| Cosmesis using digital photographs | 8 years plus or minus one year | 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. |
| Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) | 8 years plus or minus one year | 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) | 8 years plus or minus one year | 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 | 8 years plus or minus one year | Telangiectasia will be classified into four categories of surface: none, less than 1cm2, 1 to 4 cm2 and over 4cm2. |
Countries
Canada
Contacts
Primary ContactJean-Philippe Pignol, MD, PhD
Backup ContactPauline Truong, MD, MSc
Outcome results
None listed