Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- CTCAE Toxicity Assessement - Acute Toxicity
研究概览
简要总结
This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.
详细描述
Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.
Eligible breast cancer patients are randomized 1:1 into the following two groups:
- Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
- Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.
Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.
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
- Single (Outcomes Assessor)
盲法说明
Radiation toxicity will be analysed by a blind second investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 18;
- •Breast cancer stage T1 - T3;
- •At least 1 lymph node positive;
- •Treated with mastectomy or conservative surgery;
- •Negative surgical margins;
- •No distant metastasis;
- •No supraclavicular or internal mammary nodes metastases;
- •Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
- •Signed informed consent.
排除标准
- •Positive surgical margins;
- •Concomitant chemotherapy;
- •Supraclavicular or internal mammary nodes metastases;
- •Distant metastasis;
- •Previous thoracic radiotherapy;
- •Bilateral breast cancer;
- •Patients with collagen diseases;
- •Unable or unwilling to sign inform consent.
研究组 & 干预措施
Conventional radiotherapy
50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery.
Total time: 5-6 weeks.
干预措施: Conventional radiotherapy (Radiation)
Hypofractionated radiotherapy
40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla).
Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed.
Total time: 3 weeks.
干预措施: Hypofractionated radiotherapy (Radiation)
结局指标
主要结局
CTCAE Toxicity Assessement - Acute Toxicity
时间窗: Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received.
Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.
次要结局
- Quality of Life - EORTC QLQ-C30 (version 3)(Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.)
- Quality of Life - EORTC breast cancer module (BR23)(Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.)