A Phase II Study of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Gastric Carcinomatosis or Positive Cytology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy
研究概览
简要总结
The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.
详细描述
HIPEC Treatment:
If you are found to be eligible to take part in this study, on the day of HIPEC treatment, you will receive heated mitomycin-C and cisplatin as a liquid that is injected through 3 to 4 small incisions in your abdomen for about 1 hour. This will be done as a surgical procedure, and you will be under general anesthesia. The chemotherapy will then be flushed out of your abdomen and collected, and the treatment area inside your abdomen will be washed. Also during the HIPEC procedure, fluid will be collected and checked for cancer cells. As is standard of care, any lesions that are found during treatment may also be biopsied at this time, if the study doctor thinks it is necessary. You may receive up to 5 HIPEC treatments on this study.
You will also receive sodium thiosulfate by vein over about 20 minutes to protect the kidneys.
You will remain in the hospital for 3-7 days after treatment.
While you are in the hospital after surgery:
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
- •Age 18 years and above. There will be no upper age restriction.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
- •Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL.
- •Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
- •Distant Metastatic Disease limited to peritoneum and radiologically occult (not visualized on preoperative imaging to include [Computerized Tomography] CT scan, Ultrasound, [Magnetic Resonance Imaging] MRI, PET/CT): a. Positive peritoneal cytology; b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
- •Completion of preoperative systemic chemotherapy.
排除标准
- •Distant metastatic disease not limited to peritoneum: a. Solid organ metastases (liver, central nervous system, lung).
- •Any distant metastatic disease visualized on preoperative imaging: a. Solid organ metastases; b. Clear radiologic evidence of carcinomatosis.
- •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
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.
干预措施: Mitomycin C (Drug)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.
干预措施: Cisplatin (Drug)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.
干预措施: Sodium Thiosulfate (Drug)
结局指标
主要结局
Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy
时间窗: Between the second and sixth week after treatment, up to 5 years
Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.
Overall Survival (OS) From the First Laparoscopic HIPEC
时间窗: From the day of surgery, until the last day of follow up, until death, up to 5 years
Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.
次要结局
未报告次要终点