NCT02240524Unknown3 期
A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy
Affiliated Cancer Hospital & Institute of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 582 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 < age ≤ 65 years old
- •Male or Non pregnant female
- •The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- •Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
- •Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
- •White blood cells > 4,000/mm3
- •neutrophils ≥ 1,500/mm3
- •platelets ≥ 100,000/mm3
- •hemoglobin>9g/l
- •Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)
- •total bilirubin (TBIL) < 1.5 times ULN
- •serum creatinine < 1 times ULN
- •Having given written informed consent prior to any procedure related to the study
排除标准
- •Existence of macroscopic peritoneal implants
- •Prior malignant tumors with detectable signs of recurrence or distant metastasis
- •Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- •Receiving other cytotoxic chemotherapy
- •High grade of intra-abdominal adhesions
- •Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
结局指标
主要结局
Overall survival
时间窗: 5 years
From the date of surgery to the date of death or to the end of follow-up
次要结局
- Hepatic metastases-free survival(5 years)
- Recurrence-free survival(5 years)
- Locoregional-free survival(5 years)
研究者
研究点 (1)
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