NCT02114359已完成3 期
Comparison of Efficacy and Tolerance Between Combination Therapy and Monotherapy as a First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer; Multicenter Randomized Phase 3 Study
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
- 111
- 试验地点
- 14
- 主要终点
- comparison of overall survival
研究概览
简要总结
The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the 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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
- •70 yrs or older
- •Eastern Cooperative Oncology Group 0-2
- •Measurable or evaluable disease
- •Adequate major organ functions
- •Hb ≥ 9.0 g/dL
- •White blood cell count ≥ 3000/μL
- •Absolute Neutrophil Count (ANC) ≥ 1500/μL [*ANC = neutrophil segs ＋ neutrophil bands]
- •Platelet ≥ 100 × 103/ μL
- •Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
- •Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine > 1.5 mg/dL , Ccr should be >= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
- •Life expectancy > 3month
- •Written informed consent
排除标准
- •Metastatic or recurrent stomach cancer other than adenocarcinoma
- •HER-2 positive
- •Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
- •Radiation therapy within the previous 2wks
- •Major surgery or trauma within the previous 4wks
- •Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
- •Uncontrolled brain metastasis
- •Presence of other serious disease (cardiovascular, hepatic, infection etc.)
- •Patients who participated in other clinical trials within the previous 30days
- •Men of childbearing potential not willing to use effective means of contraception
研究组 & 干预措施
Platinum/fluoropyrimidine combination chemotherapy
Experimental
干预措施: Capecitabine/cisplatin (Drug)
Platinum/fluoropyrimidine combination chemotherapy
Experimental
干预措施: S-1/cisplatin (Drug)
Platinum/fluoropyrimidine combination chemotherapy
Experimental
干预措施: Capecitabine/oxaliplatin (Drug)
Platinum/fluoropyrimidine combination chemotherapy
Experimental
干预措施: 5-fluorouracil/oxaliplatin (Drug)
Fluoropyrimidine monochemotherapy
Active Comparator
干预措施: Capecitabine (Drug)
Fluoropyrimidine monochemotherapy
Active Comparator
干预措施: S-1 (Drug)
Fluoropyrimidine monochemotherapy
Active Comparator
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
comparison of overall survival
时间窗: upto 3years
次要结局
- comparison of progression-free survival(upto 2years)
- comparison of response rate(upto 2years)
- comparison of adverse events(upto 2yrs)
- comparison of quality of life(upto 2years)
研究者
In Sil Choi
Clinical Associate Professor, Department of Internal Medicine
SMG-SNU Boramae Medical Center
研究点 (14)
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