Xiangdong Cheng1, Dan Wu2, Nong Xu3, Luchuan Chen4, Zhilong Yan5, Ping Chen6, Lei Zhou7, Jianfa Yu8, Jiuwei Cui9, Wei Li9, Chang Wang9, Wenming Feng10, Yunhai Wei11, Pengfei Yu12, Yian Du12, Jieer Ying12, Zhiyuan Xu12, Litao Yang12, Yunli Zhang12. 1. Department of Abdominal Surgery, Zhejiang Cancer Hospital (University of Chinese Academy of Sciences Cancer Hospital), Zhejiang, China. abdsurg@163.com. 2. Department of General Surgery, Second Affiliated Hospital of Medical College of Zhejiang University, Zhejiang, China. 3. Department of Oncology, First Affiliated Hospital of Medical College of Zhejiang University, Zhejiang, China. 4. Department of Gastrointestinal Oncology Surgery, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China. 5. Department of Gastrointestinal Surgery, Ningbo First Hospital, Zhejiang, China. 6. Department of Gastrointestinal Surgery, Ningbo Second Hospital, Zhejiang, China. 7. Department of General Surgery, China-Japan Friendship Hospital, Beijing, China. 8. Department of Gastrointestinal Surgery, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Zhejiang, China. 9. Oncology Central, First Hospital of Jilin University, Jilin, China. 10. Department of Hepatobiliary Pancreatic Surgery, Huzhou First People's Hospital, Zhejiang, China. 11. Department of Hepatobiliary Pancreatic Surgery, Huzhou Central Hospital (Zhejiang University Huzhou Hospital), Zhejiang, China. 12. Department of Abdominal Surgery, Zhejiang Cancer Hospital (University of Chinese Academy of Sciences Cancer Hospital), Zhejiang, China.
Abstract
BACKGROUND: Surgery is the only treatment option for operable gastric cancer. The CLASSIC and ACTS-GC studies showed that the 5-year overall survival (OS) of patients with stageIII gastric cancer undergoingD2 gastrectomy is still very low. Whether adjuvant nanoparticle albumin-bound paclitaxel (nab-paclitaxel) combined chemotherapy is more effective than the XELOX standard adjuvant chemotherapy in patients with stageIII gastric cancer has not been confirmed. METHODS: This is a multicenter, open-label, phase III clinical study. In this trial, 616 patients with locally advanced stageIII gastric cancer that underwentcurative D2 radical surgery and achieved R0 are planned to be included. Patients will be randomized 1:1 to nab-paclitaxel combined with S-1 (AS) vs. oxaliplatin combined with capecitabine (XELOX). XELOXgroup: Patients assigned to the XELOXgroup received eight 3-week cycles of oral capecitabine (1000 mg/m2) twice daily on days 1-14 of each cycle plus intravenous oxaliplatin 130 mg/m2 on day 1 of each cycle. AS group: AS group received eight 3-week cycles of oral S-1 (80-120 mg) (< 1.25 m2, 40 mg; 1.25 to < 1.5 m2, 50 mg; and > 1.5 m2, 60 mg) twice daily on days 1-14 plus intravenous nab-paclitaxel 120 mg/m2 on days 1 and 8 of each cycle. The primary endpoint was the 3-year disease-free survival (3-year-DFS) defined as the time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause. The secondary endpoints were the overall survival, (defined as the time from the date of randomisation to date of death from any cause) and safety (any adverse event). DISCUSSION: Compared with previous studies, this study includes nab-paclitaxel based on S-1 adjuvant chemotherapy, which is expected to achieve better efficacy and lower toxicity than the standard treatment. This study is the first clinical study to evaluate the safety and efficacy of nab-paclitaxel combined with S-1 in patients with stage III gastric cancer after D2 radical resection. TRIAL REGISTRATION: This clinical trial has been registered with ClinicalTrials.gov, registration number: NCT04135781 , on October 20th, 2019.
RCT Entities:
BACKGROUND: Surgery is the only treatment option for operable gastric cancer. The CLASSIC and ACTS-GC studies showed that the 5-year overall survival (OS) of patients with stage III gastric cancer undergoing D2 gastrectomy is still very low. Whether adjuvant nanoparticle albumin-bound paclitaxel (nab-paclitaxel) combined chemotherapy is more effective than the XELOX standard adjuvant chemotherapy in patients with stage III gastric cancer has not been confirmed. METHODS: This is a multicenter, open-label, phase III clinical study. In this trial, 616 patients with locally advanced stage III gastric cancer that underwent curative D2 radical surgery and achieved R0 are planned to be included. Patients will be randomized 1:1 to nab-paclitaxel combined with S-1 (AS) vs. oxaliplatin combined with capecitabine (XELOX). XELOX group: Patients assigned to the XELOX group received eight 3-week cycles of oral capecitabine (1000 mg/m2) twice daily on days 1-14 of each cycle plus intravenous oxaliplatin 130 mg/m2 on day 1 of each cycle. AS group: AS group received eight 3-week cycles of oral S-1 (80-120 mg) (< 1.25 m2, 40 mg; 1.25 to < 1.5 m2, 50 mg; and > 1.5 m2, 60 mg) twice daily on days 1-14 plus intravenous nab-paclitaxel 120 mg/m2 on days 1 and 8 of each cycle. The primary endpoint was the 3-year disease-free survival (3-year-DFS) defined as the time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause. The secondary endpoints were the overall survival, (defined as the time from the date of randomisation to date of death from any cause) and safety (any adverse event). DISCUSSION: Compared with previous studies, this study includes nab-paclitaxel based on S-1 adjuvant chemotherapy, which is expected to achieve better efficacy and lower toxicity than the standard treatment. This study is the first clinical study to evaluate the safety and efficacy of nab-paclitaxel combined with S-1 in patients with stage III gastric cancer after D2 radical resection. TRIAL REGISTRATION: This clinical trial has been registered with ClinicalTrials.gov, registration number: NCT04135781 , on October 20th, 2019.
Authors: D Takahari; T Hamaguchi; K Yoshimura; H Katai; S Ito; N Fuse; T Kinoshita; H Yasui; M Terashima; M Goto; N Tanigawa; K Shirao; T Sano; M Sasako Journal: Cancer Chemother Pharmacol Date: 2010-09-01 Impact factor: 3.333