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临床试验/NCT03092518
NCT03092518已完成2 期

Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2017年6月5日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: Surgery (Procedure)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: Cisplatin (Drug)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: Mitomycin C (Drug)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: Sodium Thiosulfate (Drug)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: Tumor Biopsy (Procedure)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: CT C/A/P (Diagnostic Test)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: PET-CT (Diagnostic Test)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

干预措施: MRI (Diagnostic Test)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Experimental

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

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Jeremy Davis, M.D.

Investigator

National Cancer Institute (NCI)

研究点 (1)

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