RecruitingPhase 2NCT05753306

Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial


Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study (ROBO-CHIP) is testing whether robotic surgery combined with heated chemotherapy delivered directly into the abdomen (HIPEC) can effectively treat stomach cancer that has spread to the lining of the belly in a limited way. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with gastric (stomach) adenocarcinoma or certain types of esophageal-gastric junction cancer confirmed by biopsy - Your cancer has spread only within the abdominal lining (not to other distant organs) - Your general health and organ function (blood counts, kidney, liver, nutrition) meet the required levels - You are physically active enough to handle treatment (ECOG performance status 0–2) **You may NOT be eligible if...** - Your cancer has spread to organs outside the abdomen - Your blood counts, kidney, or liver function do not meet the required levels - You have poor nutritional status Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Given via HIPEC

PROCEDUREComputed Tomography

Undergo CT scan or PET/CT

PROCEDUREGastrectomy

Undergo robotic gastrectomy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PE/CT

OTHERQuestionnaire Administration

Complete questionnaire

DRUGPaclitaxel

Given via HIPEC

DRUGHyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05753306


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