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Prophylactic Hyperthermic IntraperitOneal Chemotherapy (p-HIPEC) for pRevention of perItONeal Recurrence in Gastric Cancer: MC240402 (HORIZON) Trial
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
December 3, 2025
Primary Completion Date
May 3, 2027
Completion Date
November 3, 2031
Last Updated
December 31, 2025
16
ESTIMATED participants
Biopsy Procedure
PROCEDURE
Biospecimen Collection
PROCEDURE
Cisplatin
DRUG
Computed Tomography
PROCEDURE
Hyperthermic Intraperitoneal Chemotherapy
DRUG
Laparoscopy
PROCEDURE
Lymphadenectomy
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Paclitaxel
DRUG
Positron Emission Tomography
PROCEDURE
Surgical Procedure
PROCEDURE
Lead Sponsor
Mayo Clinic
NCT05911243
NCT04929392
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