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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07139951
Phase
PHASE2
Status
Enrolling By Invitation

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo laparoscopy with biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cisplatin — DRUG
    Given IP
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Hyperthermic Intraperitoneal Chemotherapy — DRUG
    Given p-HIPEC
  • Laparoscopy — PROCEDURE
    Undergo laparoscopy with biopsy
  • Lymphadenectomy — PROCEDURE
    Undergo D2 lymphadenectomy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Paclitaxel — DRUG
    Given IP
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT or PET/MRI
  • Surgical Procedure — PROCEDURE
    Undergo gastrectomy and reconstruction

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Dec 2025
Primary completion
May 3, 2027
Completion
Nov 3, 2031

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (p-HIPEC, cisplatin, paclitaxel)
    Patients undergo gastrectomy with reconstruction per surgeon discretion and D2 lymphadenectomy and receive p-HIPEC with cisplatin and paclitaxel intraperitoneal (IP) over 90 minutes on study. Patients also undergo blood sample collection and PET/CT or PET/MRI throughout the study, as well as laparoscopy with biopsy during screening.

Primary Outcome Measure

Peritoneal Recurrence-free Survival [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

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