A Pragmatic Randomised, Multicentre Trial Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Endocrine toxicity
研究概览
简要总结
REaCT-RETT will demonstrate the non-inferiority of concurrent compared to sequential endocrine therapy in patients receiving post-operative radiotherapy for early stage breast cancer.
详细描述
Clinical equipoise exists around the optimal time to start adjuvant endocrine therapy in patients who will receive post-operative radiotherapy for breast cancer. Patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. A recent survey of Canadian oncologists showed that the main reason for prescribing sequential endocrine therapy was a concern that concurrent endocrine therapy and radiotherapy would worsen the toxicity of endocrine treatment. This is despite the absence of any clinical trial evidence to support this. Indeed, a recent systematic review by our group was unable to confirm or refute whether increased toxicities, related to the timing of endocrine therapy and radiotherapy actually exist in clinical practice. The investigators are therefore proposing a pragmatic randomised trial to assess whether or not concurrent endocrine therapy and radiotherapy worsens endocrine treatment-related symptoms in an era of modern endocrine and radiation therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed early stage, hormone receptor positive breast cancer
- •Planned to receive both endocrine therapy and post-operative radiotherapy
- •Able to provide verbal consent
排除标准
- •Previous endocrine therapy for invasive breast cancer
- •Previous radiotherapy for breast cancer in the same breast
研究组 & 干预措施
Concurrent Endocrine Therapy and Radiotherapy
Concurrent endocrine therapy and radiotherapy. Concurrent endocrine therapy will be defined as, the commencement of endocrine therapy around 2 weeks before (a minimum of 1 week before to a maximum of 4 weeks) commencement of radiotherapy and continued throughout radiotherapy.
干预措施: Endocrine Therapy and Radiotherapy (Combination Product)
Sequential Endocrine Therapy after Radiotherapy
Sequential endocrine therapy after radiotherapy. Using the pragmatic definition sequential endocrine therapy should commence around 2 weeks (minimum 1 week, maximum 4 weeks) after the last fraction of radiotherapy.
干预措施: Endocrine Therapy and Radiotherapy (Combination Product)
结局指标
主要结局
Endocrine toxicity
时间窗: 12 months (+/- 2 weeks) post final fraction of radiotherapy
To measure endocrine toxicity. The Functional Assessment of Cancer Therapy - Endocrine Sub-scale (FACT-ES) is a questionnaire specific to patients with endocrine symptoms and measures the side effects and putative benefits of hormonal treatments given (endocrine therapy) in breast cancer. The FACT-ES questionnaire is comprised of 5 sections; physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and additional concerns (19 questions). A total of 46 questions are asked that all contain an answer on a scale range of 0-4, with 0 representing the answer 'not at all' and 4 representing the answer 'very much'. Of the 46 questions asked 31/46 have 'very much' representing the worst answer and the remaining 15/46 have 'very much' representing the best answer.
次要结局
- Radiotherapy toxicity(12 months (+/- 2 weeks) post final fraction of radiotherapy)
- Rates of starting endocrine therapy and compliance(12 months (+/- 2 weeks) post final fraction of radiotherapy)
- Direct Estimation of Health Utility Values(12 months (+/- 2 weeks) post final fraction of radiotherapy)
- Incremental cost-effectiveness ratios(12 months (+/- 2 weeks) post final fraction of radiotherapy)
- Exploratory analyses on evaluating radiotherapy toxicity(12 months (+/- 2 weeks) post final fraction of radiotherapy)
