NCT07139951
Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for Gastric Cancer at High Risk of Peritoneal Recurrence
Enrolling by Invitation
PHASE2Ages 18–80InterventionalTreatmentMayo ClinicInvestigator-initiated
~16 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionCisplatinComputed TomographyHyperthermic Intraperitoneal ChemotherapyLaparoscopy
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peritoneal Recurrence-free Survival
Measured over Up to 18 months
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Travis E. Grotz, MD, MS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age ≥ 18 and ≤ 80 years
Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction (GEJ) (Siewert type II or III)
Tumor index (TI) ≥ 90 (T stage multiplied by the largest tumor diameter in mm on endoscopic ultrasound \[EUS\]). Patients with linitus plastica automatically have TI ≥ 90
Hemoglobin ≥ 8.0 g/dL
Absolute neutrophil count (ANC) ≥ 1000/mm\^3
Platelet count ≥ 75,000/mm\^3
Calculated creatinine clearance ≥ 60 ml/min using the Cockcroft-Gault formula
No radiographic or histological evidence of distant metastasis
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion
Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \< 60)
Or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Active second malignancy currently receiving systemic treatment ≤ 6 months prior to pre-registration
History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
What this trial measures
- Peritoneal Recurrence-free SurvivalUp to 18 months
Patients will be followed in active surveillance with biomarkers (CEA and CA 19-9) and cross-sectional imaging of the chest, abdomen and pelvis. Only non-lymphatic, non-peranastomotic, and non-visceral intra-abdominal metastasis will be considered peritoneal metastasis. Ovarian metastasis will be considered peritoneal metastasis for this trial.