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Gastric AdenocarcinomaCancerGut healthDrugProcedureRadiationPhase 2

What this study is

This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.

What's being tested

  • Capecitabine

    Intervention · DRUG

  • Chemotherapy

    Intervention · DRUG

    Receive induction chemotherapy

  • Conventional Surgery

    Intervention · PROCEDURE

    Undergo surgery

  • Fluorouracil

    Intervention · DRUG

  • Radiation Therapy

    Intervention · RADIATION

    Undergo RT

Both Capecitabine and Fluorouracil

Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.

Study details

Official title
A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases
Sponsor
M.D. Anderson Cancer Center
Conditions
Gastric Adenocarcinoma · Oligometastasis · Stage IV Esophageal Adenocarcinoma AJCC v7 · Stage IV Esophageal Cancer AJCC v7 · Stage IV Gastric Cancer AJCC v7
Enrolling
100 people
Starts
2018-02-19
Est. completion
2026-12-31
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗