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

NCT05753306 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 22-004680NCI-2023-00431
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (3)

• Hospital length of stay

  Recorded as number of days in hospital following surgery.

  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

  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)

  Up to 30 days post surgery

Secondary Outcomes (5)

• Operative time

  Intraoperative

• Opioid consumption

  Up to 3 years

• Nursing reported pain scores

  Up to 3 years

• Recurrence-Free Survival (RFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

Treatment (gastrectomy, HIPEC)

EXPERIMENTAL

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.

Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Gastrectomy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Paclitaxel; Drug: Hyperthermic Intraperitoneal Chemotherapy

Interventions

Cisplatin DRUG

Given via HIPEC

Also known as: 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

Treatment (gastrectomy, HIPEC)

Gastrectomy PROCEDURE

Undergo robotic gastrectomy

Also known as: Gastric Resection

Treatment (gastrectomy, HIPEC)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Treatment (gastrectomy, HIPEC)

Positron Emission Tomography PROCEDURE

Undergo PE/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (gastrectomy, HIPEC)

Questionnaire Administration OTHER

Complete questionnaire

Treatment (gastrectomy, HIPEC)

Paclitaxel DRUG

Given via HIPEC

Also known as: 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

Treatment (gastrectomy, HIPEC)

Hyperthermic Intraperitoneal Chemotherapy DRUG

Undergo HIPEC

Also known as: HIPEC

Treatment (gastrectomy, HIPEC)

Computed Tomography PROCEDURE

Undergo CT scan or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (gastrectomy, HIPEC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Gastrectomy; Magnetic Resonance Spectroscopy; Paclitaxel; taxane; Taxes; Albumin-Bound Paclitaxel; Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Digestive System Surgical Procedures; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Travis E Grotz, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: April 20, 2023
• Primary Completion (Estimated): March 25, 2030
• Study Completion (Estimated): March 25, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)