A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years or older
- •Histologically confirmed squamous cell carcinoma of esophagus
- •Curatively (R0) resected, lymph node positive
- •ECOG performance status of 0 or 1
- •Restoration of oral intake >1500 kcal/d
- •No prior chemotherapy except for neoadjuvant ones
- •No prior radiotherapy within 1 month before registration
- •Adequate marrow, hepatic, renal and cardiac functions
- •Provision of a signed written informed consent
排除标准
- •Severe co-morbid illness and/or active infections
- •Prior treatment with oxaliplatin
- •Pregnant or lactating women
- •Active CNS metastases not controllable with radiotherapy or corticosteroids
- •Known history of hypersensitivity to study drugs
研究组 & 干预措施
LV5FU2
leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2
干预措施: oxaliplatin (Drug)
FOLFOX
leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
干预措施: oxaliplatin (Drug)
结局指标
主要结局
disease-free survival
时间窗: 36 months
次要结局
未报告次要终点