Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Breast fibrosis
研究概览
简要总结
The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.
The main question[s] it aims to answer are:
- evaluate the rate of all grades of radiation-induced fibrosis at 4 years.
- evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)
详细描述
This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (< or= 50 years) and additional risk factors for local recurrence.
The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.
The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven breast cancer who have undergone conservative surgery
- •at least 3 inserted clips
- •age: from 18 years old to 50 years
- •at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (>25%), close margins (<4 mm), non-hormone-sensitive disease, grading 3
- •ECOG performance status < 2
- •adequate bone marrow (haemoglobin concentration > 8 g/dl, white blood cell count > 3000/mm3, platelet count > 75000).
排除标准
- •Previous chest radiation treatment
- •Bilateral breast cancer
- •Neoadjuvant chemotherapy
- •BMI > 35
- •Collagen diseases
- •Pregnancy or breastfeeding
研究组 & 干预措施
Hypofractionated arm + concomitant tumor bed boost
Hypofractionation arm, 40 Gy in 15 fractions (2.67 Gy per fraction over 3 weeks) and a tumor bed boost to a total dose of 52.5 Gy in 15 fractions (3.5 Gy per fraction over 3 weeks).
干预措施: hypofractionated radiotherapy with tumor bed boost (Radiation)
结局指标
主要结局
Breast fibrosis
时间窗: baseline, each year up to 4 years after radiotherapy
Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale
次要结局
- Breast cosmesis(baseline, each year up to 4 years after radiotherapy)
- Quality of Life (QOL)(baseline, each year up to 4 years after radiotherapy)