NCT02038621Unknown2 期
Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
The Second People's Hospital of Sichuan0 个研究点目标入组 224 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 224
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)
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
- •Age ≥ 18 years old
- •male or female
- •Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
- •ECOG performance status score 0-2 ;
- •Expected survival time more than three months ;
- •Adequate hematologic parameters and liver and kidney function ;
- •Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
- •Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
- •Renal : serum creatinine ≤ ULN ;
- •Informed consent of patients or their agents , and signed informed consent.
排除标准
- •For patients allergic to capecitabine ;
- •Patients with CNS metastases
- •Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
- •Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
- •Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
- •Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
- •The researchers believe that this test is not suitable for those who participate .
研究组 & 干预措施
A
Experimental
Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance.
干预措施: Paclitaxel (Drug)
A
Experimental
Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance.
干预措施: Oxaliplatin and Capecitabine (Drug)
B
Placebo Comparator
Observation until progression
干预措施: Paclitaxel (Drug)
B
Placebo Comparator
Observation until progression
干预措施: Oxaliplatin and Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
次要结局
- overall survival (OS)(from the date of randomization until death from any cause or up to 1 year)
- adverse events (AE)(from date of randomization to 28 days after the last chemo dosage)
- health-related quality of life (HRQOL(evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage)
研究者
Chengya Chou
Oncology physician
The Second People's Hospital of Sichuan
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