Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for the Treatment of Patients With Gastric and Gastroesophageal Junction Adenocarcinoma at High Risk of Peritoneal Recurrence

Summary

This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal \[IP\]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal cavity (peritoneal) after a period of improvement (recurrence). Recurrence in the peritoneum often occurs within the first 18 months after surgery. This is thought to be due to tumor cells that may scatter and spread during surgery. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Paclitaxel alone and in combination with other chemotherapy agents have been shown to be effective treatments for gastric tumors. However, systemic delivery of these drugs has not been shown to be effective in treating peritoneal metastasis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure that involves the infusion of a heated chemotherapy solution, such as cisplatin and paclitaxel, that circulates into the abdominal cavity. Giving HIPEC with cisplatin and paclitaxel at the time of surgery may reduce peritoneal recurrence in patients with gastric or gastroesophageal junction adenocarcinoma at high risk.

Conditions

• Clinical Stage I Gastric Cancer AJCC v8
• Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage II Gastric Cancer AJCC v8
• Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage III Gastric Cancer AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

DRUG

Paclitaxel

Given IP

PROCEDURE

Positron Emission Tomography

Undergo PET/CT or PET/MRI

PROCEDURE

Surgical Procedure

Undergo gastrectomy and reconstruction

PROCEDURE

Biopsy Procedure

Undergo laparoscopy with biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cisplatin

Given IP

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Hyperthermic Intraperitoneal Chemotherapy

Given p-HIPEC

PROCEDURE

Laparoscopy

Undergo laparoscopy with biopsy

PROCEDURE

Lymphadenectomy

Undergo D2 lymphadenectomy

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Travis E. Grotz, MD, MS · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-03

Primary Completion

2027-05-03

Completion

2031-11-03

FDA Drug

Yes

Countries

• United States

Study Locations