Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Second progress-free survival
研究概览
简要总结
To assess the optimal sequence of the palliative chemotherapy regimen (DP --> FOLFIRI vs FOLFIRI --> DP) in metastatic gastric cancer patients.
详细描述
Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.
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
- •Histologically confirmed metastatic adenocarcinoma of the stomach
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Life expectancy of at least 3 months
- •Adequate renal, liver, bone marrow functions
- •Adjuvant chemotherapy more than 12 months from the date of study entry
- •Written informed consent
排除标准
- •Active infection requiring antibiotics
- •Pregnant, lactating women
- •Brain metastasis
- •Systemic illness not appropriate for chemotherapy
- •Radiotherapy within 2 weeks before the study entry
- •Allergy to drugs used in the trial
研究组 & 干预措施
FOLFIRI
干预措施: FOLFIRI (Drug)
DP
D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr, D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr
D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
干预措施: DP (Drug)
结局指标
主要结局
Second progress-free survival
时间窗: 2years
次要结局
- Toxicity, overall survival(2years)