Back to resultsRobotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
Primary Purpose
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Cisplatin
Computed Tomography
Docetaxel
Gastrectomy
Hyperthermic Intraperitoneal Chemotherapy
Magnetic Resonance Imaging
Positron Emission Tomography
Questionnaire Administration
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma
Eligibility 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (gastrectomy, HIPEC)
Arm Description
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.
Outcomes
Primary Outcome Measures
Hospital length of stay
Descriptive statistics such as mean, standard deviation, median and range summarized.
30 day readmission rate
Descriptive statistics such as mean, standard deviation, median and range summarized.
30 day Clavien-Dindo grade III complications
Descriptive statistics such as mean, standard deviation, median and range summarized.
Secondary Outcome Measures
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.
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.
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.
Open conversion rate
Descriptive statistics such as mean, standard deviation, median and range summarized.
Opioid consumption in morphine milligram equivalents
Descriptive statistics such as mean, standard deviation, median and range summarized.
Nursing reported pain scores
Descriptive statistics such as mean, standard deviation, median and range summarized.
Estimated blood loss
Descriptive statistics such as mean, standard deviation, median and range summarized.
Operative time
Descriptive statistics such as mean, standard deviation, median and range summarized.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05753306
Brief Title
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
Official Title
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (gastrectomy, HIPEC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo stool and blood sample collection
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
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
Intervention Description
Given via HIPEC
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT scan or PET/CT
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given via HIPEC
Intervention Type
Procedure
Intervention Name(s)
Gastrectomy
Other Intervention Name(s)
Gastric Resection
Intervention Description
Undergo robotic gastrectomy
Intervention Type
Drug
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy
Other Intervention Name(s)
HIPEC
Intervention Description
Undergo HIPEC
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
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
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PE/CT
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 1 year
Title
30 day readmission rate
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 30 days post surgery
Title
30 day Clavien-Dindo grade III complications
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 30 days post surgery
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
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.
Time Frame
Up to 5 years
Title
Peritoneal recurrence free survival
Description
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.
Time Frame
Up to 5 years
Title
Overall survival
Description
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.
Time Frame
Up to 5 years
Title
Open conversion rate
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 42 months
Title
Opioid consumption in morphine milligram equivalents
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 42 months
Title
Nursing reported pain scores
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 42 months
Title
Estimated blood loss
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Up to 42 months
Title
Operative time
Description
Descriptive statistics such as mean, standard deviation, median and range summarized.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Travis E Grotz
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Travis E. Grotz, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
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