Trial Title:
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
NCT ID:
NCT05753306
Condition:
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Metastatic Malignant Neoplasm in the Peritoneum
Conditions: Official terms:
Adenocarcinoma
Neoplasms
Cisplatin
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo stool and blood sample collection
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given via HIPEC
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan or PET/CT
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Given via HIPEC
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Docecad
Other name:
RP56976
Other name:
Taxotere
Other name:
Taxotere Injection Concentrate
Intervention type:
Procedure
Intervention name:
Gastrectomy
Description:
Undergo robotic gastrectomy
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Gastric Resection
Intervention type:
Drug
Intervention name:
Hyperthermic Intraperitoneal Chemotherapy
Description:
Undergo HIPEC
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
HIPEC
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PE/CT
Arm group label:
Treatment (gastrectomy, HIPEC)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaire
Arm group label:
Treatment (gastrectomy, HIPEC)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Travis E. Grotz, M.D.
Email:
Principal Investigator
Start date:
March 16, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05753306
https://www.mayo.edu/research/clinical-trials
