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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05753306
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Metastatic Malignant Neoplasm in the Peritoneum

Eligibility Criteria

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

Interventions

  • Cisplatin — DRUG
    Given via HIPEC
  • Computed Tomography — PROCEDURE
    Undergo CT scan or PET/CT
  • Gastrectomy — PROCEDURE
    Undergo robotic gastrectomy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PE/CT
  • Questionnaire Administration — OTHER
    Complete questionnaire
  • Paclitaxel — DRUG
    Given via HIPEC
  • Hyperthermic Intraperitoneal Chemotherapy — DRUG
    Undergo HIPEC

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
Apr 2026
Primary completion
Mar 25, 2030
Completion
Mar 25, 2030

Study Design

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

Arms

  • Experimental: Treatment (gastrectomy, HIPEC)
    Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.

Primary Outcome Measure

Hospital length of stay [ Time Frame: Up to 30 days post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Travis E. Grotz, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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