NCT01099085已完成3 期
Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Progression free survival of XP ± simvastatin
研究概览
简要总结
Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.
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
- Double (Participant, Investigator)
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 or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
- •patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
- •measurable or evaluable disease according to RECIST
- •age, 18 years or older
- •ECOG performance status 0 - 2
- •adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 3.0 mg/dL
- •signed written informed consent
排除标准
- •severe co-morbid illness and/or active infections
- •pregnant or lactating women
- •active CNS metastases not controllable with radiotherapy or corticosteroids
- •active and uncontrollable bleeding from gastrointestinal tract
- •known history of hypersensitivity to study drugs
- •patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)
研究组 & 干预措施
XP/simvastatin
Active Comparator
Capecitabine/cisplatin + simvastatin
干预措施: Simvastatin (Drug)
XP/placebo
Placebo Comparator
Capecitabine/cisplatin + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Progression free survival of XP ± simvastatin
时间窗: 1-year PFS
次要结局
未报告次要终点
研究者
Won Ki Kang
Professor
Samsung Medical Center
研究点 (1)
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