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NCT Number: NCT05753306

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

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.

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Key information

Conditions

Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Metastatic Malignant Neoplasm in the Peritoneum

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Travis E. Grotz, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

Drug

Given via HIPEC

Other names: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Computed Tomography

Procedure

Undergo CT scan or PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

gastrectomy

Procedure

Undergo robotic gastrectomy

Other names: Gastric Resection

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Positron Emission Tomography

Procedure

Undergo PE/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Questionnaire Administration

Other

Complete questionnaire

paclitaxel

Drug

Given via HIPEC

Other names: Taxane, Taxol, 5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine, Taxol Konzentrat, Praxel, Abraxane, Naveruclif, Pazenir

Hyperthermic Intraperitoneal Chemotherapy

Drug

Undergo HIPEC

Other names: HIPEC

Primary outcomes

  1. Hospital length of stay

    Time frame: Up to 30 days post-surgery

    Recorded as number of days in hospital following surgery.

  2. 30 day readmission rate

    Time frame: Up to 30 days post-surgery

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

  3. Adverse Events

    Time frame: Up to 30 days post surgery

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

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

    Recorded as the time from incision to close

  2. Opioid consumption

    Time frame: Up to 3 years

    Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery.

  3. Nursing reported pain scores

    Time frame: Up to 3 years

    As recorded (mean and max) during hospitalization and post-surgery follow-up visits

  4. Recurrence-Free Survival (RFS)

    Time frame: Up to 3 years

    Assessed from the date of gastrectomy and hyperthermic intraperitoneal chemotherapy (HIPEC). Patterns of tumor recurrence will be assessed by reviewing routine surveillance imaging.

  5. Overall Survival (OS)

    Time frame: Up to 3 years

    Defined as the time from gastrectomy and HIPEC until death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Mar 3, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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