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Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for the Treatment of Patients With Gastric and Gastroesophageal Junction Adenocarcinoma at High Risk of Peritoneal Recurrence

NCT ID: NCT07139951

Last Updated: 2025-12-31

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2031-11-03

Brief Summary

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This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal \[IP\]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal cavity (peritoneal) after a period of improvement (recurrence). Recurrence in the peritoneum often occurs within the first 18 months after surgery. This is thought to be due to tumor cells that may scatter and spread during surgery. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Paclitaxel alone and in combination with other chemotherapy agents have been shown to be effective treatments for gastric tumors. However, systemic delivery of these drugs has not been shown to be effective in treating peritoneal metastasis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure that involves the infusion of a heated chemotherapy solution, such as cisplatin and paclitaxel, that circulates into the abdominal cavity. Giving HIPEC with cisplatin and paclitaxel at the time of surgery may reduce peritoneal recurrence in patients with gastric or gastroesophageal junction adenocarcinoma at high risk.

Detailed Description

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Conditions

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Clinical Stage I Gastric Cancer AJCC v8 Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage II Gastric Cancer AJCC v8 Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (p-HIPEC, cisplatin, paclitaxel)

Patients undergo gastrectomy with reconstruction per surgeon discretion and D2 lymphadenectomy and receive p-HIPEC with cisplatin and paclitaxel intraperitoneal (IP) over 90 minutes on study. Patients also undergo blood sample collection and PET/CT or PET/MRI throughout the study, as well as laparoscopy with biopsy during screening.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo laparoscopy with biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Cisplatin

Intervention Type DRUG

Given IP

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Hyperthermic Intraperitoneal Chemotherapy

Intervention Type DRUG

Given p-HIPEC

Laparoscopy

Intervention Type PROCEDURE

Undergo laparoscopy with biopsy

Lymphadenectomy

Intervention Type PROCEDURE

Undergo D2 lymphadenectomy

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Paclitaxel

Intervention Type DRUG

Given IP

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT or PET/MRI

Surgical Procedure

Intervention Type PROCEDURE

Undergo gastrectomy and reconstruction

Interventions

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Biopsy Procedure

Undergo laparoscopy with biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Cisplatin

Given IP

Intervention Type DRUG

Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

Given p-HIPEC

Intervention Type DRUG

Laparoscopy

Undergo laparoscopy with biopsy

Intervention Type PROCEDURE

Lymphadenectomy

Undergo D2 lymphadenectomy

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Paclitaxel

Given IP

Intervention Type DRUG

Positron Emission Tomography

Undergo PET/CT or PET/MRI

Intervention Type PROCEDURE

Surgical Procedure

Undergo gastrectomy and reconstruction

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection 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 CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography HIPEC LP excision of the lymph node Lymph Node Dissection Lymph Node Excision Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Operation Surgery Surgery Type Surgery, NOS Surgical Surgical Intervention Surgical Interventions Surgical Procedures Type of Surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Travis E. Grotz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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NCI-2025-05845

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-013133

Identifier Type: OTHER

Identifier Source: secondary_id

MC240402

Identifier Type: OTHER

Identifier Source: secondary_id

MC240402

Identifier Type: -

Identifier Source: org_study_id