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Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer

NCT03161522 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Gastric Adenocarcinoma
  • Oligometastasis
  • Stage IV Esophageal Adenocarcinoma AJCC v7
  • Stage IV Esophageal Cancer AJCC v7
  • Stage IV Gastric Cancer AJCC v7

Interventions

DRUG

Capecitabine

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

DRUG

Chemotherapy

Receive induction chemotherapy

PROCEDURE

Conventional Surgery

Undergo surgery

DRUG

Fluorouracil

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

RADIATION

Radiation Therapy

Undergo RT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Quynh-Nhu Nguyen · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161522 on ClinicalTrials.gov