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RecruitingNCT05753306

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCisplatinGiven via HIPEC
PROCEDUREComputed TomographyUndergo CT scan or PET/CT
PROCEDUREGastrectomyUndergo robotic gastrectomy
PROCEDUREMagnetic Resonance ImagingUndergo MRI
PROCEDUREPositron Emission TomographyUndergo PE/CT
OTHERQuestionnaire AdministrationComplete questionnaire
DRUGPaclitaxelGiven via HIPEC
DRUGHyperthermic Intraperitoneal ChemotherapyUndergo HIPEC

Timeline

Start date
2023-04-20
Primary completion
2030-03-25
Completion
2030-03-25
First posted
2023-03-03
Last updated
2026-04-08

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05753306. Inclusion in this directory is not an endorsement.