Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Major complication
研究概览
简要总结
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
详细描述
Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being(PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction.
In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages.
Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.
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 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of stage I-III breast cancer (non-T4), >18 years old;
- •Complete breast cancer resection (including skin-sparing and nipple-sparing total resection)
- •According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required;
- •Undergo immediate reconstructive surgery (tissue dilator or permanent implant)
排除标准
- •Auto-reconstruction surgery
- •Clinical or pathological T4
- •Both sides need radiotherapy
- •Have a history of chest radiotherapy
- •Pregnancy/lactation
- •Participate in other drug clinical trials
研究组 & 干预措施
conventional fraction radiotherapy
Total dose of plan tumor volume is 5000 cGy,and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.
干预措施: Conventional fraction radiotherapy (Radiation)
hypofractioned radiotherapy
Total dose of plan tumor volume is 4050 cGy,and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.
干预措施: Hypofractionated Radiation Therapy (Radiation)
结局指标
主要结局
Major complication
时间窗: From enrollment to the end of treatment at 24 months
implant related complications requiring reoperation such as severe necrosis,severe infections, severe capsular contracture, implant rupture and implant exposure.
次要结局
- Any breast-related complications(From enrollment to the end of treatment at 24 months)
- Absolute reconstruction failure(From enrollment to the end of treatment at 24 months)
- Oncologic outcomes(From enrollment to the end of treatment at 5 years)
- Cosmetic outcomes(From enrollment to the end of treatment at 24 months)
研究者
Sun Xinchen
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
The First Affiliated Hospital with Nanjing Medical University
