Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- 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 Design
Arms and Interventions
| 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: Biospecimen Collection
Undergo stool and blood sample collection
Other Names:
Drug: Cisplatin
Given via HIPEC
Other Names:
Procedure: Computed Tomography
Undergo CT scan or PET/CT
Other Names:
Drug: Docetaxel
Given via HIPEC
Other Names:
Procedure: Gastrectomy
Undergo robotic gastrectomy
Other Names:
Drug: Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Other Names:
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
Procedure: Positron Emission Tomography
Undergo PE/CT
Other Names:
Other: Questionnaire Administration
Complete questionnaire
|
Outcome Measures
Primary Outcome Measures
- Hospital length of stay [Up to 1 year]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- 30 day readmission rate [Up to 30 days post surgery]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- 30 day Clavien-Dindo grade III complications [Up to 30 days post surgery]
Descriptive statistics such as mean, standard deviation, median and range summarized.
Secondary Outcome Measures
- Disease-free survival [Up to 5 years]
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.
- Peritoneal recurrence free survival [Up to 5 years]
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.
- Overall survival [Up to 5 years]
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.
- Open conversion rate [Up to 42 months]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- Opioid consumption in morphine milligram equivalents [Up to 42 months]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- Nursing reported pain scores [Up to 42 months]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- Estimated blood loss [Up to 42 months]
Descriptive statistics such as mean, standard deviation, median and range summarized.
- Operative time [Intraoperative]
Descriptive statistics such as mean, standard deviation, median and range summarized.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Travis E Grotz, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-004680
- NCI-2023-00431
- 22-004680