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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (gastrectomy, HIPEC)<br>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: Biospecimen Collection<br>* Undergo stool and blood sample collection<br>* Other names: Specimen Collection;Drug: Cisplatin<br>* Given via HIPEC<br>* Other names: Platosin;Procedure: Computed Tomography<br>* Undergo CT scan or PET/CT<br>* Other names: tomography;Drug: Docetaxel<br>* Given via HIPEC<br>* Other names: Taxotere Injection Concentrate;Procedure: Gastrectomy<br>* Undergo robotic gastrectomy<br>* Other names: Gastric Resection;Drug: Hyperthermic Intraperitoneal Chemotherapy<br>* Undergo HIPEC<br>* Other names: HIPEC;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Positron Emission Tomography<br>* Undergo PE/CT<br>* Other names: PT;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
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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 |