Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial.

IF 3.3 2区医学 Q2 ONCOLOGY

Radiation Oncology Pub Date : 2024-05-27 DOI:10.1186/s13014-024-02449-y

Kairui Jin, Jurui Luo, Xiaoli Yu, Xiaomao Guo

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引用次数: 0

Abstract

Background: The effectiveness and safety of moderately hypofractionated radiotherapy (HFRT) in patients undergoing breast-conserving surgery (BCS) has been demonstrated in several pivotal randomized trials. However, the feasibility of applying simultaneous integrated boost (SIB) to the tumor bed and regional node irradiation (RNI) using modern radiotherapy techniques with HFRT needs further evaluation.

Methods: This prospective, multi-center, randomized controlled, non-inferiority phase III trial aims to determine the non-inferiority of HFRT combined with SIB (HFRTsib) compared with conventional fractionated radiotherapy with sequential boost (CFRTseq) in terms of five-year locoregional control rate in breast cancer patients undergoing upfront BCS. A total of 2904 participants will be recruited and randomized in a 1:1 ratio into the HFRTsib and CFRTseq groups. All patients will receive whole breast irradiation, and those with positive axillary nodes will receive additional RNI, including internal mammary irradiation. The prescribed dose for the HFRTsib group will be 40 Gy in 15 fractions, combined with a SIB of 48 Gy in 15 fractions to the tumor bed. The CFRTseq group will receive 50 Gy in 25 fractions, with a sequential boost of 10 Gy in 5 fractions to the tumor bed.

Discussion: This trial intends to assess the effectiveness and safety of SIB combined with HFRT in early breast cancer patients following BCS. The primary endpoint is locoregional control, and the results of this trial are expected to offer crucial evidence for utilizing HFRT in breast cancer patients after BCS.

Trial registration: This trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019.

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在接受前期保乳手术的乳腺癌患者中采用肿瘤床同步增强的低分次放疗（Hi-RISE）：III 期随机对照试验的研究方案。

背景：多项关键性随机试验证明，对接受保乳手术（BCS）的患者进行适度低分次放疗（HFRT）是有效和安全的。然而，利用现代放疗技术对肿瘤床和区域结节同时进行综合增量（SIB）照射（RNI）和低分次放射治疗（HFRT）的可行性还需要进一步评估：这项前瞻性、多中心、随机对照、非劣效性III期试验旨在确定，在接受前期BCS治疗的乳腺癌患者中，就五年局部控制率而言，HFRT联合SIB（HFRTsib）与传统的分次增强放疗（CFRTseq）相比是否具有非劣效性。该研究将招募 2904 名参与者，按 1:1 的比例随机分为 HFRTsib 组和 CFRTseq 组。所有患者都将接受全乳腺照射，腋窝结节阳性的患者将接受额外的RNI，包括乳腺内照射。HFRTsib组的规定剂量为40 Gy，15次分次照射，肿瘤床的SIB剂量为48 Gy，15次分次照射。CFRTseq组将在25个分次中接受50 Gy的照射，并在5个分次中对肿瘤床进行10 Gy的连续增强照射：本试验旨在评估SIB联合HFRT对BCS术后早期乳腺癌患者的有效性和安全性。主要终点是局部控制，该试验的结果有望为乳腺癌患者在BCS术后使用HFRT提供重要证据：本试验于2019年7月18日在ClincalTrials.gov（NCT04025164）上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Radiation Oncology ONCOLOGY-RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

CiteScore

6.50

自引率

2.80%

发文量

181

审稿时长

3-6 weeks

期刊介绍： Radiation Oncology encompasses all aspects of research that impacts on the treatment of cancer using radiation. It publishes findings in molecular and cellular radiation biology, radiation physics, radiation technology, and clinical oncology.

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