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Brief Title: Perioperative Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Locally Advanced Gastric or Gastroesophageal Junction Cancer
Official Title: A Phase II Trial of Perioperative Chemotherapy With Leucovorin, Oxaliplatin, Docetaxel and S-1 (LOTS) For Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Study ID: NCT04999332
Brief Summary: The aim of the trial is to investigate the clinical efficacy and toxicity of perioperative chemotherapy with leucovorin, oxaliplatin, docetaxel and S-1 (LOTS) in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who receive a curative surgery.
Detailed Description: The study is an open-label, single-arm, single-country and multi-center phase II investigator-initiated trial. Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who enroll the trial will receive perioperative chemotherapy with LOTS (14 days as a cycle) 4 cycles every 2 weeks, followed by operation and another 4 cycles every 2 weeks post-operatively. The primary outcome is pathological response or curative resection rate. The secondary outcome includes recurrence-free survival, overall survival, disease control rate, protocol completion rate and adverse events.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Kaohsiung Veterans General Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Name: Chia Jui Yen, M.D., Ph.D.
Affiliation: Department of Oncology, National Cheng Kung University Hospital
Role: STUDY_CHAIR
Name: Yan Shen Shan, M.D., Ph.D.
Affiliation: Department of Surgery, National Cheng Kung University Hospital
Role: STUDY_DIRECTOR
Name: I Shu Chen, M.D.
Affiliation: Department of General Surgery, Kaohsiung Veterans General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Li Yuan Bai, M.D., Ph.D.
Affiliation: Department of Hematology/Oncology, China Medical University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ming Huang Chen, M.D., Ph.D.
Affiliation: Department of Oncology, Taipei Veterans General Hospital
Role: PRINCIPAL_INVESTIGATOR