Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
详细描述
Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed metastatic or recurrent gastric cancer
- •with at least one measurable lesion by RECIST criteria
- •an age of ≥ 18
- •adequate oral intake
- •no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)
- •an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •adequate bone marrow function, hepatic function and renal functions
排除标准
- •a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
- •serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
- •extensive bone metastasis, brain metastasis or meningeal metastasis
- •another synchronous cancer
- •surgery within 3 weeks before enrollment
- •participating in other clinical studies
- •women who were or to be pregnant, nursing infants, and men who were to conceive children
研究组 & 干预措施
S-1 plus LV
All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks.
干预措施: S-1 (Drug)
S-1 plus LV
All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks.
干预措施: LV (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 year
The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.
次要结局
- Progression free survival (PFS)(1-1.5 years)
- Overall survival (OS)(1-2.5 years)
- Time to treatment failure (TTF)(1 year)
- Disease control rate(1 year)
- Adverse Events (AEs)(2 year)
研究者
Ruihua Xu
vice president of SunYat-sen University Cancer Center,head of medical oncology department
Sun Yat-sen University