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

Phase 2

Suspended

• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Neoplasm in the Peritoneum
• Interventions: Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Docetaxel; Procedure: Gastrectomy; Drug: Hyperthermic Intraperitoneal Chemotherapy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

• Registration Number: NCT05753306
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.

SECONDARY OBJECTIVES:

I. To obtain a biorepository for additional translational research including:

Ia. Stool samples for shotgun metagenomic sequencing and metabolomic quantification of the fecal microbiome before and after gastrectomy; Ib. Blood and peritoneal tissue biobanked for future investigations; Ic. Patient reported outcomes using the Mayo Clinic Upper Digestive Disease Survey questionnaires at 1, 3, 6 and 12 months.

OUTLINE:

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 computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT scans throughout the trial.

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Study Start: 2023-04-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-03-25
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (gastrectomy, HIPEC)	Biospecimen Collection	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.
Treatment (gastrectomy, HIPEC)	Computed Tomography	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.
Treatment (gastrectomy, HIPEC)	Gastrectomy	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.
Treatment (gastrectomy, HIPEC)	Hyperthermic Intraperitoneal Chemotherapy	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.
Treatment (gastrectomy, HIPEC)	Magnetic Resonance Imaging	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.
Treatment (gastrectomy, HIPEC)	Positron Emission Tomography	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.
Treatment (gastrectomy, HIPEC)	Questionnaire Administration	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.
Treatment (gastrectomy, HIPEC)	Cisplatin	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.
Treatment (gastrectomy, HIPEC)	Docetaxel	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 Measures

Name	Time	Method
Hospital length of stay	Up to 30 days post-surgery	Recorded as number of days in hospital following surgery.
30 day readmission rate	Up to 30 days post-surgery	Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery
Adverse Events	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 Outcome Measures

Name	Time	Method
Disease-free survival	Up to 5 years	Defined as the length of time from surgery until recurrence of disease (signs or symptoms of cancer)
Peritoneal recurrence free survival	Up to 5 years	Defined as the time from surgery until recurrence of peritoneal cancer
Overall survival	Up to 5 years	Defined as the time from surgery until death due to any cause
Opioid consumption	Up to 42 months	Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery.
Nursing reported pain scores	Up to 42 months	As recorded during hospitalization and post-surgery follow-up visits
Operative time	Intraoperative	Recorded as the time from incision to close

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States