A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.
SECONDARY OBJECTIVES:
I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
OUTLINE:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
- •Leukocytes >= 3,000/uL
- •Absolute neutrophil count >= 1,500/uL
- •Platelets >= 60,000/Ul
- •Serum creatinine =< 1.5 mg/dL
- •Distant metastatic disease of peritoneum may be visualized on imaging:
- •Positive peritoneal cytology
- •Carcinomatosis on diagnostic laparoscopy or laparotomy
- •Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC
排除标准
- •Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung)
- •Infections such as pneumonia or wound infections that would preclude protocol therapy
- •Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
- •Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
- •Subjects deemed unable to comply with study and/or follow-up procedures
- •Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
研究组 & 干预措施
Treatment (mitomycin, cisplatin)
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
干预措施: Cisplatin (Drug)
Treatment (mitomycin, cisplatin)
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
干预措施: Hyperthermic Intraperitoneal Chemotherapy (Drug)
Treatment (mitomycin, cisplatin)
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
干预措施: Mitomycin (Drug)
结局指标
主要结局
Overall Survival
时间窗: Date of diagnosis to date of death or last follow-up
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer
次要结局
- Clavien-Dindo Surgical Complications(90-days from surgery)