Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
NCT ID: NCT05753306
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-04-20
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Cisplatin
Given via HIPEC
Computed Tomography
Undergo CT scan or PET/CT
Gastrectomy
Undergo robotic gastrectomy
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PE/CT
Questionnaire Administration
Complete questionnaire
Paclitaxel
Given via HIPEC
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Interventions
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Cisplatin
Given via HIPEC
Computed Tomography
Undergo CT scan or PET/CT
Gastrectomy
Undergo robotic gastrectomy
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PE/CT
Questionnaire Administration
Complete questionnaire
Paclitaxel
Given via HIPEC
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Travis E Grotz, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-00431
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-004680
Identifier Type: OTHER
Identifier Source: secondary_id
22-004680
Identifier Type: -
Identifier Source: org_study_id
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