A multicenter, randomized, phase III trial of short-term radiotherapy plus chemotherapy versus long-term chemoradiotherapy in locally advanced rectal cancer (STELLAR): The final reports.

作者：Jing Jin, Yuan Tang, Chen Hu, Yong Cai, Yuan Zhu, Guanghui Cheng, Hongyan Zhang, Xin Wang, Suyu Zhu, Jun Wang, Gaofeng Li, Jialin Yang, Kuan Zhang, Yihebali Chi, Haitao Zhou, Lichun Wei, Wenling Wang, Shixin Liu, Yuanhong Gao, Ye‐Xiong Li · 发表于：Journal of Clinical Oncology · 年份：2021 · DOI：10.1200/jco.2021.39.15_suppl.3510 · 被引用次数：40 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Colorectal Cancer Treatments and Studies

3510 Background: It’s presented the results of a phase III trial of short-term radiotherapy (SCRT) combined with chemotherapy versus long-term chemoradiotherapy (LCRT) in patients with locally advanced rectal cancer (LARC). Methods: Patients with distal or middle third, T3-T4 and/or N+ rectal adenocarcinomas diagnosed by MRI, were randomly assigned to experimental group or control group. In experimental group, patients received SCRT (25 Gy / 5 fractions / 5 days), followed by four courses of CAPOX. In control group, patients received LCRT (50 Gy / 25 fractions / 35 days with concurrent capecitabine). Surgery was recommended in both groups and performed 6-8 weeks after preoperative treatment. Two or six courses of CAPOX was prescribed as the postoperative chemotherapy in experimental group and control group, respectively. This trial was a multicenter, open-label, randomized, noninferior, phase III study, and all the patients were from 16 hospitals of China. The primary endpoint for this study was 3-year disease-free survival (DFS). Results: From Aug 30, 2015 to Aug 27, 2018, 599 patients were enrolled and entered random. Finally, 591 intention-to-treat (ITT) populations were included in the analysis, 298 patients assigned to SCRT followed by chemotherapy and 293 to CRT. For the experimental group and control group, cT3 and cT4 accounted for 82.3% vs. 84.6% and 15.4% vs. 12.3%, respectively, and approximately 85% were mrN positive (85.6% vs. 84.0%). As a whole, the completion a...