PDF(Pubmed)
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.
CONCLUSIONS: 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.
BACKGROUND: This trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019.
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.
CONCLUSIONS: 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.
BACKGROUND: This trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019.
摘要：
背景：在接受保乳手术（BCS）的患者中，中度大分割放疗（HFRT）的有效性和安全性已在几个关键的随机试验中得到证实。然而,使用现代放射治疗技术和HFRT对瘤床和区域淋巴结照射(RNI)同时进行整合增强(SIB)的可行性需要进一步评估.
方法：这种前瞻性，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,HFRT联合SIB(HFRTsib)在5年局部控制率方面的非劣效性与常规分割放疗序贯增强(CFRTseq)相比.总共2904名参与者将被招募并以1：1的比例随机分配到HFRTsib和CFRTseq组中。所有患者将接受全胸照射，腋窝淋巴结阳性的人将接受额外的RNI，包括乳腺内照射.HFRTsib组的处方剂量为40Gy，分15次，结合48Gy的SIB在15个部分的肿瘤床。CFRTseq组将在25个馏分中获得50Gy，在5个部分中连续增加10Gy到肿瘤床。
结论：本试验旨在评估SIB联合HFRT在BCS术后早期乳腺癌患者中的有效性和安全性。主要终点是局部控制，这项试验的结果有望为BCS后乳腺癌患者使用HFRT提供关键证据.
背景：该试验于2019年7月18日在ClincalTrials.gov（NCT04025164）注册。
方法：这种前瞻性，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,HFRT联合SIB(HFRTsib)在5年局部控制率方面的非劣效性与常规分割放疗序贯增强(CFRTseq)相比.总共2904名参与者将被招募并以1：1的比例随机分配到HFRTsib和CFRTseq组中。所有患者将接受全胸照射，腋窝淋巴结阳性的人将接受额外的RNI，包括乳腺内照射.HFRTsib组的处方剂量为40Gy，分15次，结合48Gy的SIB在15个部分的肿瘤床。CFRTseq组将在25个馏分中获得50Gy，在5个部分中连续增加10Gy到肿瘤床。
结论：本试验旨在评估SIB联合HFRT在BCS术后早期乳腺癌患者中的有效性和安全性。主要终点是局部控制，这项试验的结果有望为BCS后乳腺癌患者使用HFRT提供关键证据.
背景：该试验于2019年7月18日在ClincalTrials.gov（NCT04025164）注册。
