Phase II Clinical Trial of Cisplatin,Docetaxel and S-1 as First Line Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall survival time (OS)
研究概览
简要总结
The combination of Cisplatin and S-1 (CS) achieved a response rate of approximately 45% with the PFS being around 6 months and overall survival time being 13 months in Japanese and Chinese gastric patients. It remains unclear whether the addition of docetaxel to CS would further enhance the efficacy as it dose in DCF(docetaxel, cisplatin and 5-fluorouracil). This is a single center, phase II clinical trial to evaluate the efficacy of docetaxel, cisplatin and S-1 (DCS) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.
详细描述
This is a single arm trial. All Patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and S-1. Given the severe toxicity of DCF regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. For patients with CR/PR/SD disease after 6 cycles of chemotherapy, maintenance therapy with S-1 are recommended. Antitumor activity will be evaluated every two cycles according to RECIST1.1.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer;
- •No previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control;
- •At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-1;
- •Recovery from the toxicities of previous therapy;
- •Adequate bone marrow and organ function. Hb≥8 G/L; Absolute neutrophil ≥ 2.0 G/L; PLT ≥100 G/L ;ALT/AST ≤1.5 ULN or ≤5ULN with liver metastases; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
- •Life expectancy ≥3 months;
- •For men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration;
- •Signed informed consent.
排除标准
- •Pathology type other than adenocarcinoma,such as squamous cell carcinoma;
- •Previous treatment with taxanes, cisplatin or S-1;
- •Relapse within 6 months after the end of adjuvant chemotherapy;
- •Known brain metastases;
- •Complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding;
- •Known deficiency of DPD enzyme;
- •Kown HIV infecton or drug addiction;
- •Any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators;
- •Myocardial infarction within 6 months prior to the entry of this trial;
- •Known history of allergic reaction to taxanes and platinum;
- •Pregnant or breast feeding women.
研究组 & 干预措施
docetaxel, cisplatin and S-1 (DCS)
All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
干预措施: Docetaxel (Drug)
docetaxel, cisplatin and S-1 (DCS)
All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
干预措施: Cisplatin (Drug)
docetaxel, cisplatin and S-1 (DCS)
All patients receive the combination therapy of docetaxel, cisplatin and S-1 for a maximum of 6 cycles. Docetaxel 60mg/m2 IV infusion over 1 hour on d1; Cisplatin 30mg/m2 IV infusion on d1,2; S-1 40mg orally twice a day for patients with the body surface area (BSA) less than 1.25m2, 50mg twice a day with the BSA between 1.25 and 1.5m2, 60mg twice a day with the BSA over 1.5m2.
干预措施: S-1 (Drug)
结局指标
主要结局
overall survival time (OS)
时间窗: 14 months
To determine the OS of DCS in patients with chemo-naive, advanced gastric or gastroesophageal junction cancer.
次要结局
- Progression free survival (PFS)(6 months)
- safety profile(4 months)
研究者
Aiping Zhou
Associate professor
Chinese Academy of Medical Sciences