Heated chemo during surgery may stop stomach Cancer's return
NCT ID NCT07139951
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests whether giving heated chemotherapy directly into the abdomen during surgery can prevent stomach or gastroesophageal junction cancer from returning in the abdominal lining. The treatment uses drugs cisplatin and paclitaxel, which are heated and circulated in the belly to kill any stray cancer cells. The trial enrolls 16 high-risk patients with stage I-III cancer. The main goal is to see if this approach extends the time before cancer reappears in the abdomen.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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