Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Background:
- Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs. Researchers want to see if a new treatment helps. It is surgical removal of the cancer and heated chemotherapy delivered to the abdominal cavity called Hyperthermic intraperitoneal chemotherapy (HIPEC).
Objective:
- To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers.
Eligibility:
- People ages 18 and older with gastric cancer who can have most tumors surgically removed
Design:
- Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Scans
- Tissue sample from previous surgery
- Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach. It and takes a sample of stomach tissue. Participants may get medicine to make them drowsy.
- Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is inserted into the abdomen. Participants sleep through the procedure.
Participants will stay in the hospital. They will have:
- Surgery to remove as many tumors as possible.
- HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs are given through one tube. They are drained out through another at a temperature a few degrees above normal body temperature. Another drug is given in a vein.
- Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and intravenous (IVs) for a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as needed.
- Participants will have visits every few months for 3 years, then one a year. Visits include physical exam, blood tests, and scans. They also include dietary assessment and questions.
详细描述
Background:
- An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.).
- The peritoneal surface is a site of metastasis found often at time of diagnosis and is a common (40%) site of recurrence.
- Laparoscopy with peritoneal lavage and cytopathologic analysis is a staging modality that can identify a subset of patients with microscopic peritoneal metastasis prior to consideration for definitive surgical therapy.
- Intraperitoneal chemotherapy has been employed in advanced gastric cancers and as an adjuvant with an associated improvement in survival in systematic reviews.
Objectives:
- Determine the overall survival in patients with cytology-positive gastric cancer treated with Hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy.
Eligibility:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: Surgery (Procedure)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: Cisplatin (Drug)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: Mitomycin C (Drug)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: Sodium Thiosulfate (Drug)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: Tumor Biopsy (Procedure)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: CT C/A/P (Diagnostic Test)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: PET-CT (Diagnostic Test)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: MRI (Diagnostic Test)
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
干预措施: EKG (Diagnostic Test)
结局指标
主要结局
Overall Survival (OS)
时间窗: 53.7 months
OS is defined as the median amount of time a participant survives after therapy.
次要结局
- Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months(6 months, 12 months and 18 months)
- Extra-peritoneal Disease-free Survival(48.9 months)
- Number of Treatment Related Serious and/or Non-serious Adverse Events by Type(Up to 1646 days)
研究者
Jeremy Davis, M.D.
Investigator
National Cancer Institute (NCI)
