Phase II Study of Laparoscopic Heated Chemotherapy and Chemoradiation Before Surgery for Stomach Cancer

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04308837

Provider View

This clinical trial is exploring a new treatment approach for patients with advanced stomach cancer. It combines heated chemotherapy delivered directly to the abdomen with radiation therapy before surgery to see if it can better control the cancer and improve survival rates.

Patient Parameters

Program Overview

Stomach cancer is a common and serious type of cancer. Treating it often requires a team of specialists, including surgeons and cancer doctors. This study is testing a new treatment plan for patients with advanced stomach cancer. It starts with a detailed scan to see how far the cancer has spread. If the cancer is advanced but hasn't spread to other parts of the body, patients will receive heated chemotherapy directly to the abdomen during a minor surgery, followed by radiation therapy. After these treatments, patients will have surgery to remove the cancer, and may receive additional chemotherapy. The goal is to see if this approach can shrink the cancer more effectively, slow its progression, and help patients live longer without the cancer coming back.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced stomach cancer (T3/T4) after an endoscopic ultrasound.
  • Cancer has not spread to other parts of the body (M0).
  • Plan to have surgery to treat the cancer.
  • Good overall health with a performance status score of 0 to 2.
  • Healthy blood and organ function based on specific medical tests.
  • Agree to use effective birth control during the study and for 90 days after treatment.
  • Able to understand and willing to sign a consent form to participate.

Exclusion Criteria

  • Have received any previous treatment for stomach cancer.
  • Cancer has spread to other parts of the body beyond lymph nodes or the abdomen.
  • Have early-stage stomach cancer (Stage T1/T2 N0).
  • Allergic to any of the study drugs, such as Carboplatin or Taxol.
  • Have had radiation to the abdomen or pelvis before.
  • Have had other cancers, unless they were treated and inactive for over three years.
  • Pregnant or breastfeeding women.
  • Have conditions that make it hard to understand the study requirements.
  • Have HIV, Hepatitis B, or Hepatitis C.
  • Have active heart disease or lung disease that could make participating risky.
  • Have a history of stroke or other severe medical issues that could interfere with the study.
  • Have extensive abdominal adhesions that prevent treatment.
  • Have a life expectancy of less than 12 weeks.

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