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RecruitingInterventionalPhase 2

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

NCT ID: NCT05753306Sponsor: Mayo ClinicLast updated: 2026-04-08

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.

Arms & 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

Outcome measures

Primary

  • Hospital length of stay

    Recorded as number of days in hospital following surgery.

    Time frame: Up to 30 days post-surgery

  • 30 day readmission rate

    Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery

    Time frame: Up to 30 days post-surgery

  • Adverse Events

    Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)

    Time frame: Up to 30 days post surgery

Secondary

  • Operative time

    Time frame: Intraoperative

  • Opioid consumption

    Time frame: Up to 3 years

  • Nursing reported pain scores

    Time frame: Up to 3 years

  • Recurrence-Free Survival (RFS)

    Time frame: Up to 3 years

  • Overall Survival (OS)

    Time frame: Up to 3 years

Eligibility criteria

Sex: AllAge: 18 Years to 80 YearsHealthy volunteers: No
Inclusion Criteria: * Restricted to 18 to 80 years of age * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas * Absolute neutrophil count \>= 1,500 / uL * Platelets \>= 50,000 / Ul * Serum creatinine \<= 1.5 mg / dL * Adequate nutritional status (Albumin \>= 3.5) * Metastasis confined to the peritoneum: * Positive peritoneal cytology * Peritoneal metastasis on diagnostic laparoscopy * Peritoneal metastasis on imaging * Response to systemic chemotherapy defined as at least one of the following: * Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\] * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\>= 20% decrease in the longest diameter of target lesion) RECIST criteria * Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology * Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9 * Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction * Body Mass Index (BMI) =\< 35 kg/m\^2 Exclusion Criteria: * Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc) * Malignant ascites at time of study enrollment * Comorbidities that would preclude protocol therapy * Subjects deemed unable to comply with study and/or follow-up procedures * Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Study locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Travis E. Grotz, MD · Principal Investigator
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study | Cancerify