Study on Heated Chemotherapy with Cisplatin and Paclitaxel for Treating Stomach and Gastroesophageal Cancer at High Risk of Returning

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT07139951

Provider View

This clinical trial is exploring a treatment that uses heated chemotherapy directly in the abdomen during surgery to help prevent the return of stomach or gastroesophageal cancer in patients at high risk of recurrence.

Patient Parameters

Program Overview

This study is testing a treatment called Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for patients with stomach or gastroesophageal cancer that is likely to come back in the abdomen. HIPEC involves using heated chemotherapy drugs, cisplatin and paclitaxel, directly in the abdominal area during surgery. This approach aims to kill any remaining cancer cells and reduce the chance of the cancer returning. Cisplatin and paclitaxel are drugs that stop cancer cells from growing and dividing. The study hopes to show that this method can help prevent cancer from coming back in the abdominal cavity, which often happens within 18 months after surgery.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 80 years.
  • Diagnosed with adenocarcinoma of the stomach or gastroesophageal junction.
  • Tumor index of 90 or higher, or diagnosed with linitus plastica.
  • Hemoglobin level of at least 8.0 g/dL.
  • Neutrophil count of at least 1000/mm³.
  • Platelet count of at least 75,000/mm³.
  • Kidney function with creatinine clearance of 60 ml/min or higher.
  • No signs of cancer spread to distant areas.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Willing to provide blood and tissue samples for research.
  • Willing to return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing individuals, or those who can have children but are not using contraception.
  • Serious health conditions that could interfere with the study.
  • Uncontrolled illnesses like infections, heart failure, or unstable chest pain.
  • Kidney problems with low filtration rate.
  • Mental health or social issues affecting study participation.
  • Taking other experimental treatments for cancer.
  • Having another active cancer treated within the last 6 months.
  • Recent heart attack or severe heart failure requiring ongoing treatment.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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