Infusional Fluorouracil and Weekly Docetaxel as First-line Therapy for Gastric Cancer With Bone Marrow Metastasis and Disseminated Intravascular Coagulation: a Multi-center, Phase II Trail
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- hematological response rate (HeRR)
研究概览
简要总结
A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).
详细描述
5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG PS 0-3;
- •Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction;
- •Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
- •overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria;
- •Treatment-naive after the diagnosis of metastasis;
- •Platelet ≤ 50 * 10E9/L;
- •ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN;
- •Written informed consent.
排除标准
- •Concurrent aggressive malignancy;
- •Docetaxel containing perioperative treatment within 6 months;
- •Allergic to the study drugs;
- •Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
- •HIV positive;
- •Her-2 gene overexpression;
- •Inadequate contraceptive measures.
研究组 & 干预措施
LD-FUD (Zhen Long)
5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
干预措施: 5-fluorouracil (Drug)
LD-FUD (Zhen Long)
5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.
干预措施: Docetaxel (Drug)
结局指标
主要结局
hematological response rate (HeRR)
时间窗: 2 months
percentage of participants whose platelet restored to normal range
次要结局
- one-month mortality (OMM)(30 days)
- time to hematological response (TTHeR)(2 months)
- overall survival (OS)(2 years)
- toxicities(2 months)
- quality of life assessed by EORTC QOL C-30 and STO-22 (QoL)(3 months)
研究者
Jian Xiao
MD
Sixth Affiliated Hospital, Sun Yat-sen University