Multi-institutional phase II study of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for breast cancer in Japan: Kyoto Radiation Oncology Study Group (UPBEAT study). (23rd November 2022)

• Record Type: Journal Article
• Authors: Mitsuyoshi, Takamasa; Ono, Yuka; Ashida, Ryo; Yamashita, Mikiko; Tanabe, Hiroaki; Takebe, Sayaka; Tokiwa, Mariko; Suzuki, Eiji; Imagumbai, Toshiyuki; Yoshimura, Michio; Yamauchi, Chikako; Mizowaki, Takashi; Kokubo, Masaki
• Is Part Of: Japanese journal of clinical oncology. Volume 53:Number 2(2023)
• Page Start: 174
• Page End: 178
• Publication Date: 2022-11-23
• Subjects: breast cancer -- phase II study -- ultra-hypofractionated -- whole-breast irradiation; Oncology -- Periodicals; Cancer -- Periodicals; 616.994005
• DOI: 10.1093/jjco/hyac174
• Languages: English
• ISSNs: 0368-2811

Abstract

Abstract: Purpose: The UK-FAST-Forward study showed that ultra-hypofractionated whole-breast irradiation (ultra-HF-WBI) involving five fractions of 26 Gy radiation over 1 week was not inferior to HF-WBI. However, it is not used in Japan due to safety concerns. In April 2022, we commenced a multi-institutional, single-arm, phase II trial. Our aim is to confirm the safety of ultra-HF-WBI after breast-conserving surgery (BCS) for breast cancer in Japanese women. Method: We plan to enroll 98 patients from 13 institutions. The primary endpoint is the proportion of late adverse events of grades ≥2 within 3 years. Discussion: We believe that this highly promising clinical study can positively impact the Japanese guidelines for breast cancer treatment. The results will help us decide whether or not ultra-HF-WBI can be used as a more convenient alternative to WBI. Registration number and date: This trial was registered in the UMIN Clinical Trials Registry (UMIN000047080) on March 4, 2022. Abstract : This multi-institutional, single-arm, phase II trial is aimed at confirming the safety of ultra-HF-WBI after BCS for breast cancer in Japanese women.