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Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for the Treatment of Patients With Gastric and Gastroesophageal Junction Adenocarcinoma at High Risk of Peritoneal Recurrence
Sponsor: Mayo Clinic
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.
Official title: Prophylactic Hyperthermic IntraperitOneal Chemotherapy (p-HIPEC) for pRevention of perItONeal Recurrence in Gastric Cancer: MC240402 (HORIZON) Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-12-03
Completion Date
2031-11-03
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
Biopsy Procedure
Undergo laparoscopy with biopsy
Biospecimen Collection
Undergo blood sample collection
Cisplatin
Given IP
Computed Tomography
Undergo PET/CT
Hyperthermic Intraperitoneal Chemotherapy
Given p-HIPEC
Laparoscopy
Undergo laparoscopy with biopsy
Lymphadenectomy
Undergo D2 lymphadenectomy
Magnetic Resonance Imaging
Undergo PET/MRI
Paclitaxel
Given IP
Positron Emission Tomography
Undergo PET/CT or PET/MRI
Surgical Procedure
Undergo gastrectomy and reconstruction
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States