A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1
研究概览
简要总结
Primary Objective:
- To compare the 3-year progression free survival (PFS) in the two treatment arms.
Secondary Objectives:
- Overall survival (OS).
- Postoperative pathological stage and R0 (complete) resection rate.
- Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.
详细描述
Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with S-1. Participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with S-1. All participants were followed during and after the study treatment until death or disease progression, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Surgery + Adjuvant Chemotherapy (SC)
Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 milligrams per square meter (mg/m^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).
干预措施: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil) (Drug)
Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)
Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).
干预措施: Docetaxel (XRP6976) (Drug)
Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)
Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).
干预措施: Oxaliplatin (SR96669) (Drug)
Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)
Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years).
干预措施: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil) (Drug)
结局指标
主要结局
Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1
时间窗: 3 years
PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as follows: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.
次要结局
- Overall Survival (OS)(From randomization to date of death due to any cause (maximum duration: up to 10 years))
- Number of Participants With Post-Operative Pathological Stage Response(Up to 10 years)
- Percentage of Participants With R0 Resection(Up to 10 years)
- Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3(From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From randomization up to 30 days after last dose of study drug (maximum duration: up to 10 years))
- Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3(From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years))
- Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3(From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years))
- Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3(From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years))
- Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3(From Baseline up to 30 days after last dose of study drug (maximum duration: up to 10 years))