Study on Adding Radiotherapy to Usual Chemotherapy for Esophageal and Gastric Cancer That Has Spread to a Few Other Areas

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04248452

Provider View

This clinical trial is exploring whether adding radiotherapy to the standard chemotherapy treatment can better control esophageal and gastric cancer that has spread to a limited number of other areas in the body.

Patient Parameters

Program Overview

This study is investigating if adding radiotherapy to the usual chemotherapy treatment can improve outcomes for patients with esophageal and gastric cancer that has spread to a few other places (oligometastatic disease). Radiotherapy uses high-energy rays to kill cancer cells and shrink tumors. The chemotherapy drugs used, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, work by stopping cancer cells from growing, dividing, or spreading. The study aims to see if this combination works better than chemotherapy alone.

Description

The main goal of this study is to find out if adding radiation therapy to the usual chemotherapy is more effective than continuing chemotherapy alone for patients with esophageal and gastric cancer that has spread to a limited number of other areas.

Study Outline:

Step 1 (Induction Phase):

  • Patients are divided into two groups.
    • Group A: Receives oxaliplatin, leucovorin, and 5-fluorouracil through IV on specific days, repeating every 28 days for up to 4 cycles.
    • Group B: Receives oxaliplatin through IV and capecitabine orally, repeating every 21 days for up to 6 cycles.

Step 2:

  • Patients are randomly assigned to one of four groups.
    • Group C: After initial treatment, patients receive radiation therapy for up to 15 days, followed by the same chemotherapy as Group A for 2 years.
    • Group D: Continues the same chemotherapy as Group A for 2 years.
    • Group E: After initial treatment, patients receive radiation therapy for up to 15 days, followed by the same chemotherapy as Group B for 2 years.
    • Group F: Continues the same chemotherapy as Group B for 2 years.

After completing the study treatment, patients will be monitored periodically for up to 5 years. If the cancer progresses, follow-up will occur every 3 months for the first 2 years, then every 6 months up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed HER2 negative metastatic esophageal or gastric cancer.
  • Cancer must have spread to no more than 3 other areas, excluding the primary site.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Women and men must agree to use effective contraception during and after treatment.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Must be able to understand and sign a consent form.
  • HIV-positive patients are eligible if on effective treatment with undetectable viral load.
  • Patients with other cancers that do not interfere with this study are eligible.
  • Must have completed any major surgery at least 4 weeks before joining the study.
  • Must have stable disease after initial chemotherapy treatment.

Exclusion Criteria

  • Cannot have any conditions that prevent the use of 5-fluorouracil, capecitabine, or oxaliplatin.
  • Cannot have any conditions that prevent the use of radiation therapy.
  • Women must not be pregnant or breastfeeding.
  • Cannot have had prior treatment with the study chemotherapy drugs unless specific conditions are met.
  • Cannot have cancer that has spread to the central nervous system.
  • Cannot have uncontrolled illnesses that would interfere with the study.
  • Cannot have received live vaccines within 30 days before joining the study.

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