NCT01671449已完成3 期
Phase III Trial of S-1 and Cisplatin (3 Weekly) Versus S-1 and Oxaliplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer
Min-Hee Ryu9 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 9
- 主要终点
- Progression-free survival
研究概览
简要总结
A multicenter, randomized, open-label, phase III trial of S-1 plus cisplatin (3 weekly) versus S-1 plus oxaliplatin chemotherapy for the first-line treatment of advanced gastric cancer
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
- •Written informed consent before the enrollment
- •Age ≥18 years old
- •Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients able to swallow food and drugs
- •At least one measurable or evaluable lesion according to RECIST criteria version 1.1
- •Adequate bone, hepatic, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first administration of study drugs
- •Absolute neutrophil count (ANC) ≥ 1,500/ uL, platelet ≥ 100,000/ uL, haemoglobin (Hb) ≥ 9.0 g/dl,
- •Serum creatinine ≤ 1.5 mg/dL (If serum creatinine is greater than 1.5 mg/dL, creatinine clearance [Ccr] should be 60 mL/min or greater. Ccr is calculated by Cockcroft-Gault formula or 24hr urine collection)
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST/ALT levels ≤ 3.0 x ULN (AST/ALT levels ≤ 5.0 x ULN for patients with liver involvement of their cancer)
- •In patients who received adjuvant or neoadjuvant chemotherapy, completion of systemic chemotherapy 6 months before the study enrollment, and no previous administration of platinum derivatives
- •Estimated life expectancy of more than 3 months
排除标准
- •Other histologic types than adenocarcinoma
- •Recurrence within 24 weeks following completion of adjuvant chemotherapy
- •R1 gastrectomy (i.e., microscopic residual disease)
- •History of another malignancy within the last five years from the day of written informed consent except cured basal cell carcinoma of skin and cured carcinoma in situ of uterine cervix
- •Radiotherapy within 4 weeks after randomization
- •History of significant neurologic or psychiatric disorders, and presence or history of CNS metastasis
- •Major surgery within 4 weeks before study entry, or insufficient recovery from major surgery (except the patients who received only open and closure or biopsy)
- •Other serious illness or medical conditions as follows;
- •Any following conditions occurred within 6 months before study entry: myocardial infarction, severe/unstable angina, bypass surgery for coronary artery/peripheral artery, congestive heart failure (NYHA class III or IV), cerebral infarction or transient ischemic attack
- •Conduction abnormality such as 2nd degree or greater AV block or severe arrhythmia that requires medical treatments (right bundle branch block (RBBB) is eligible, but left bundle branch block (LBBB) is not.)
- •Uncontrolled hypertension
- •Liver cirrhosis (Child Pugh Class B or greater)
- •Interstitial pneumonia, pulmonary fibrosis
- •Active viral hepatitis B
- •Uncontrolled diabetes mellitus
- •Uncontrolled ascites or pleural effusion
- •Uncontrolled active infection or sepsis
- •Administration of medications which may have potentially pharmacokinetic interaction with S-1, cisplatin, and oxaliplatin
- •Flucytosine, a fluorinated pyrimidine antifungal agent
- •Anti-viral agents, such as sorivudine, and brivudine, or chemical similar drugs
- •Warfarin (except, low dose warfarin for the purpose of prophylaxis), phenprocoumon
- •Phenytoin
- •Allopurinol
- •Participation to other clinical trials or administration of other investigational drugs within 30 days before the randomisation
- •Pregnant or lactating women
- •Women or men of child bearing potential not employing adequate contraception during study treatments or until the 3 months after the end of study treatments
- •Ineligible for the study at the discretion of investigators
研究组 & 干预措施
S-1 plus Cisplatin
Active Comparator
- S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
- Cisplatin: 60 mg/ m2/day, i.v., day 1
- Every 3 weeks
干预措施: S-1 (Drug)
S-1 plus Cisplatin
Active Comparator
- S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
- Cisplatin: 60 mg/ m2/day, i.v., day 1
- Every 3 weeks
干预措施: Cisplatin (Drug)
S-1 plus Oxaliplatin
Experimental
- S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
- Oxaliplatin: 130 mg/ m2/day, i.v., day 1
- Every 3 weeks
干预措施: S-1 (Drug)
S-1 plus Oxaliplatin
Experimental
- S-1: 40 mg/m2, twice daily, p.o., day 1-14 (see Table 6 for dose calculation of S-1 according to body surface area)
: If S-1 is started on the evening of day 1, last dose of S-1 will be administered at the morning of day 15.
- Oxaliplatin: 130 mg/ m2/day, i.v., day 1
- Every 3 weeks
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
The primary endpoint of this study is progression-free survival. This is defined as the time from randomization to disease progression or death due to any cause.
次要结局
- Number of Adverse Events(Every 3 weeks)
- Overall survival(From date of randomization to death from any cause, assessed up to 3 years)
- Response rate(Every 6 weeks)
- Quality of life(Every 6 weeks)
研究者
Min-Hee Ryu
Asan Medical Center
Asan Medical Center
研究点 (9)
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