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临床试验/NCT06830083
NCT06830083招募中不适用

Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

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

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Xinchen

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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