Study on Short Course Radiation Therapy Combined with Chemotherapy for Early Stage Gastric Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07101666

This clinical trial is exploring whether adding a short course of radiation therapy to chemotherapy before surgery can improve treatment outcomes for patients with early stage gastric cancer, while reducing side effects.

Patient Parameters

Program Overview

The study aims to find out if using a short course of radiation therapy along with chemotherapy before surgery can lead to better treatment results for patients with early stage gastric cancer. The researchers believe this approach, called Total Neoadjuvant Therapy, might increase the chances of completely eliminating the cancer with fewer side effects compared to traditional methods.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with gastric adenocarcinoma, a type of stomach cancer. Tumors that extend to the gastroesophageal junction are allowed.
  • Cancer stage must be determined by specific medical imaging tests.
  • Must be medically fit to receive standard chemotherapy.
  • Aged 18 years or older.
  • In good general health, with an ECOG performance status of 0 to 2.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Kidney function with creatinine clearance over 50 mL/min.
  • Women and men must agree to use effective birth control during the study and for a period after the study ends.
  • Must be able to understand and sign a consent form, or have a representative do so on their behalf.

Exclusion Criteria

  • Have had previous surgery, radiation, or chemotherapy for stomach or esophageal cancer.
  • Have had surgery on the esophagus or stomach.
  • Have a specific type of tumor at the gastroesophageal junction (Siewert I-II).
  • Have another cancer that could interfere with the study treatment.
  • Are currently taking other experimental drugs.
  • Have a history of severe allergic reactions to similar chemotherapy drugs.
  • Have uncontrolled health issues like active infections, heart failure, or significant heart problems.
  • Are pregnant or breastfeeding. Women must have a negative pregnancy test before joining the study.
  • Have HIV and are not on effective treatment with an undetectable viral load for at least 6 months. Those on effective treatment with a stable viral load are eligible.

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