Neoadjuvant treatment for advanced gastric cancer using HIPEC and chemoradiation

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation (Carboplatin and Taxol) as First Line Treatment for Patients With Local Regional Advanced Gastric Cancer

This study is testing a new treatment combining heated chemotherapy and radiation for people with advanced stomach cancer to see if it helps them do better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT04308837 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of neoadjuvant laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) combined with chemoradiation for patients with locally advanced gastric cancer. The approach involves staging the cancer through endoscopic ultrasound and performing a diagnostic laparoscopy to assess for peritoneal metastasis. Patients who meet the criteria will receive HIPEC during the laparoscopy, followed by chemoradiation to enhance local and systemic control of the disease. The goal is to improve treatment outcomes before surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with locally advanced gastric cancer (T3/T4) who are planning to undergo surgical treatment.

Not a fit: Patients with early-stage gastric cancer or those with metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with HIPEC in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Clinical diagnosis of gastric cancer post endoscopic ultrasound (EUS), staging must be T3/T4
* N0/+, M0. EUS must have been done within 8 weeks of the protocol start.
* Patient must plan to undergo surgical treatment.
* ECOG Scale of Performance Status of 0-2
* Adequate organ and marrow function (leukocytes ≥ 3000/mcl, absolute neutrophil count ≥ 1500, platelets ≥ 100,000/mcl, total bilirubin ≥ 1.5mg/dl (Gilbert's syndrome, then \<3.0), AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal, creatinine within normal institutional limits)
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects who have any previous treatment for their cancer.
* Patients with known metastatic disease; this includes patients with clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces.
* Subjects with early stage gastric cancer (Stage T1/T2 N0)
* History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the agents being used in this study, including but not limited to: Carboplatin, Taxol, 5-FU, Leucovorin, Mitomycin C.
* Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded.
* Subjects who have had prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than three years.
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* Subjects with a condition that may interfere with the subjects' ability to understand the requirements of the study.
* Known HIV, Hepatitis B, or Hepatitis C positive patients.
* Patients with active coronary artery disease (defined as unstable angina or a positive cardiac stress test) will be excluded. Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.
* Patients with restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded.
* Patients with a history of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded.
* Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study, will also be excluded.
* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
* Patients with any condition that would precluded the ability to deliver appropriate IP therapy.
* Patients with a life expectancy of less than 12 weeks will be excluded from this study.

Where this trial is running

New York, New York and 2 other locations

• Mount Sinai West — New York, New York, United States (Recruiting)
• Mount Sinai St. Luke's — New York, New York, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Spiros Hiotis, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Spiros Hiotis, MD, PhD

Conditions Gastric Cancer; Stomach Cancer; Phase II Trial; HIPEC; Chemoradiation