Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Dose determination (Phase 1)
研究概览
简要总结
Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.
This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of gastric origin, primary or recurrent
- •Identification of Peritoneal seeding by CT or diagnostic laparoscopy
- •Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic
- •No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer
- •Labs adequate for chemotherapy (within 2 weeks of enrollment)
- •Absolute Neutrophil Count: ≧ 1,500/mm³
- •Hemoglobin level: ≧ 8.0g/dL
- •Platelet Count: ≧ 10×104/mm³
- •AST (GOT), ALT (GPT): ≦ 100U/L
- •Total Bilirubin: ≦ 2.0mg/dL
- •Creatinine Clearance (CCl): ≧ 50mL/min
- •ECOG 0 - 2
- •Her-2 negative on endoscopic biopsy
- •Age ≧ 20, < 80
- •Signed Informed consent form
排除标准
- •Patients with other major medical disease or malignant tumors other than gastric cancer
- •Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- •Pregnant, breast-feeding women or with birth plan
- •Patients refusing treatment
研究组 & 干预措施
Gastric Cancer with Peritoneal Carcinomatosis
Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
干预措施: Paclitaxel (Drug)
Gastric Cancer with Peritoneal Carcinomatosis
Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
干预措施: mFOLFOX6 regimen (Drug)
结局指标
主要结局
Dose determination (Phase 1)
时间窗: 1 Year
Dosage determination of Intraperitoneal Paclitaxel
Overall survival (Phase 2)
时间窗: 1 Year
1 year Overall survival with determined dose from Phase 1
次要结局
- Conversion surgery ratio(3 Years)
- Tumor response(3 Years)
- Progression-free survival(1 Year)
- Toxicity ratio(3 Years)
研究者
Hyung-Ho Kim
Professor
Seoul National University Bundang Hospital