NCT03092518

Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Histologically confirmed adenocarcinoma of the stomach. * Cytopathologic evidence of peritoneal carcinomatosis. * Medically fit for systemic chemotherapy, HIPEC and gastrectomy. Design: \- Single arm, Phase II study of HIPEC and gastrectomy.

Conditions

• Gastric Adenocarcinoma
• Esophagogastric Junction
• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate
DRUG	Cisplatin	Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity
DRUG	Mitomycin C	Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity
DRUG	Sodium Thiosulfate	Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.
PROCEDURE	Tumor Biopsy	At screening, baseline (if not done at screening) and operation (as clinically indicated).
DIAGNOSTIC_TEST	CT C/A/P	At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
DIAGNOSTIC_TEST	PET-CT	At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
DIAGNOSTIC_TEST	MRI	If computed tomography (CT) contraindicated.
DIAGNOSTIC_TEST	EKG	At screening and baseline (if not done at screening).

Timeline

• Start date: 2017-06-05
• Primary completion: 2024-04-05
• Completion: 2024-07-24
• First posted: 2017-03-28
• Last updated: 2025-02-19
• Results posted: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study