Long Term Outcomes of a Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
试验速览
- 阶段
- 3 期
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- Chronic breast pain using Visual Analog Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial
排除标准
- •Patients declining participating to this study
- •Patients unable to travel to the study site
- •Patients deceased
结局指标
主要结局
Chronic breast pain using Visual Analog Scale
时间窗: 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)
时间窗: 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
时间窗: 8 years plus or minus one year
The use of pain killer will be recorded.
Chronic breast pain using the McGill pain questionnaire
时间窗: 8 years plus or minus one year
Qualitatively the pain will be evaluated and scored using the short form of the McGill pain questionnaire.
次要结局
- 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)
- Cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS)(8 years plus or minus one year)
- 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)
- Skin and sub-cutaneous delayed telangiectasia(8 years plus or minus one year)
- Skin and sub-cutaneous induration(8 years plus or minus one year)
- Cosmesis using the European Organization for Research and Treatment of Cancer (EORTC) scale(8 years plus or minus one year)
- Cosmesis using digital photographs(8 years plus or minus one year)
- 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)