A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Mar 12, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for locally advanced gastric cancer, which is a serious type of stomach cancer. The study combines several methods: a type of chemotherapy delivered directly into the abdomen (called HIPEC), radiation therapy, and surgery. The aim is to see if this multi-step treatment can help shrink tumors more effectively and improve patient outcomes, such as survival rates and disease-free periods.

To participate in this trial, patients must have been diagnosed with T3 or T4 stage gastric cancer and plan to undergo surgery. They should also meet specific health criteria, including having good organ function and not having received prior cancer treatments. Participants can expect to undergo diagnostic procedures, receive the new treatment, and be closely monitored throughout the study. It's important to note that women who can become pregnant and men must agree to use contraception during the trial, as the treatments may pose risks to a developing fetus. This trial is currently recruiting patients, and those interested should discuss it with their healthcare provider.

Gender

ALL

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.