Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Post Operative Complications
研究概览
简要总结
The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.
详细描述
Treatment Plan:
Patients undergoing definitive resection for gastric cancer and meeting the eligibility criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents and will be obtained as marketed drugs.
Outcome Measures:
Patients will be followed for 90 days following surgery. All postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
Schedule for Follow Up:
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
- •Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
- •Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
- •ECOG performance status < 2
排除标准
- •Distant metastases
- •Peritoneal carcinomatosis
- •Synchronous malignancy
- •Tumors at the gastroesophageal junction
- •Recurrent gastric adenocarcinoma
- •Creatinine >/= 1.5
- •Bilirubin >/= 2
- •Allergy to drugs included in the treatment plan
- •Contraindication to major surgery
研究组 & 干预措施
HIPEC
The administration of hyperthermic intraperitoneal chemotherapy (HIPEC), using a warm solution of two chemotherapy medications (mitomycin and cisplatin) to bathe the internal surfaces of the abdomen in an attempt to kill any microscopic cancer cells that might be present on these surfaces.
干预措施: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Drug)
结局指标
主要结局
Post Operative Complications
时间窗: 90 days following surgery
Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
次要结局
未报告次要终点
研究者
Maheswari Senthil
MD
Loma Linda University