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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Travis E. Grotz, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Must enroll in Institutional Review Board (IRB) 14-009873 (NCT02530983)

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Other: Questionnaire Administration; Complete questionnaire; Drug: Hyperthermic Intraperitoneal Chemotherapy; Undergo HIPEC; Other Names: HIPEC; Drug: Cisplatin; Given via HIPEC; Other Names: CDDP; Cis-diamminedichloridoplatinum; Cismaplat; Cisplatinum; Neoplatin; Platinol; Abiplatin; Blastolem; Briplatin; Cis-diammine-dichloroplatinum; Cis-diamminedichloro Platinum (II); Cis-diamminedichloroplatinum; Cis-dichloroammine Platinum (II); Cis-platinous Diamine Dichloride; Cis-platinum; Cis-platinum II; Cis-platinum II Diamine Dichloride; Cisplatina; Cisplatyl; Citoplatino; Citosin; Cysplatyna; DDP; Lederplatin; Metaplatin; Peyrone's Chloride; Peyrone's Salt; Placis; Plastistil; Platamine; Platiblastin; Platiblastin-S; Platinex; Platinol- AQ; Platinol-AQ; Platinol-AQ VHA Plus; Platinoxan; Platinum; Platinum Diamminodichloride; Platiran; Platistin; Platosin; Procedure: Biospecimen Collection; Undergo stool and blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: Computed Tomography; Undergo CT scan or PET/CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Drug: Docetaxel; Given via HIPEC; Other Names: Taxotere; Docecad; RP56976; Taxotere Injection Concentrate; Procedure: Gastrectomy; Undergo robotic gastrectomy; Other Names: Gastric Resection; Procedure: Positron Emission Tomography; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 1 year
30 day readmission rate	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 30 days post surgery
30 day Clavien-Dindo grade III complications	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Peritoneal recurrence free survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Overall survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Open conversion rate	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Opioid consumption in morphine milligram equivalents	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Nursing reported pain scores	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Estimated blood loss	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Operative time	Descriptive statistics such as mean, standard deviation, median and range summarized.	Intraoperative

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Travis E Grotz, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: 22-004680 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-00431 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No