An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared With 5-FU and Cisplatin in Patients With Metastatic Diffuse Gastric Cancer Previously Untreated With Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 361
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.
详细描述
This is an open-label, international, Phase 3 study evaluating the efficacy and safety of the S-1/cisplatin regimen versus the 5-FU/cisplatin regimen in chemotherapy-naïve patients with metastatic diffuse gastric carcinoma including carcinoma of the gastro-esophageal junction. Patients will be randomly assigned to S-1/cisplatin (experimental regimen, Arm A) or 5-FU/cisplatin (control regimen, Arm B).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has given written Informed Consent.
- •Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction.
- •No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago.
- •Life expectancy of at least 3 months.
- •Able to take medications orally.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Adequate organ function (bone marrow, kidney and liver).
排除标准
- •Certain type(s) of non-measurable lesion(s), if the only one(s).
- •Certain serious illness or medical condition(s).
- •Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the Informed Consent Form.
- •Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
- •Pregnant or lactating female.
- •Known hypersensitivity to fluoropyrimidines or cisplatin.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
S-1+Cisplatin
Participants received S-1 25 milligrams per meter square (mg/m^2) orally twice daily (BID) every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m^2 as a 1- to 3-hour intravenous (IV) infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until progression of disease (PD), adverse event (AE), withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
干预措施: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm) (Drug)
5FU+Cisplatin
Participants received 5-Fluorouracil (5-FU) 800 mg/m^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
干预措施: Fluorouracil/cisplatin (control arm) (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)
OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.
次要结局
- Duration of Response (DR)(From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months))
- Number of Participants With TEAEs With Severity Greater Than or Equal to (>=) Grade 3(From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months))
- Time to Treatment Failure (TTF)(From date of randomization until disease progression, cut-off date: 07 March 2014 (approximately 34.7 months))
- Progression-free Survival (PFS)(From date of randomization until disease progression or death, cut-off date: 07 March 2014 (approximately 34.7 months))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)(From first dose of study medication up to 30 days of last study medication (maximum duration: 35.7 months))
- Overall Response Rate (ORR): Percentage of Participants With Overall Response(From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months))
- Time to Tumor Response (TTR)(From date of first study medication until cut-off date: 07 March 2014 (approximately 34.7 months))