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

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.

Conditions

• Gastric Adenocarcinoma
• Esophagogastric Junction
• Gastric Cancer

Interventions

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).

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jeremy L Davis, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-05

Primary Completion

2024-04-05

Completion

2024-07-24

FDA Drug

Yes

Countries

• United States

Study Locations