Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
NCT03161522

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-15

100

Participants Needed

1

Research Sites

462 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of esophageal or gastric adenocarcinoma confirmed by biopsy or FNA
  • Staged by EGD and PET/CT scan
  • Three or fewer observable metastatic lesions at diagnosis or after induction chemotherapy
  • Metastatic sites include distant M1 lymph nodes, osseous, visceral, or CNS metastases
  • ECOG performance status between 0 and 2 with life expectancy of at least 6 months
  • Age between 18 and 79 years
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for six months after the study
Not Eligible

You will not qualify if you...

  • Prior chemotherapy or radiation therapy for esophageal or gastric cancer
  • Prior radiation therapy to the same site for another cancer diagnosis
  • Presence of fistula documented by radiography or endoscopic studies
  • Life expectancy less than 6 months or ECOG performance status greater than 3
  • Pregnant women or nursing females
  • History of uncontrolled angina, congestive heart failure, or recent myocardial infarction within 6 months
  • Poor nutritional status
  • Severely depressed bone marrow function or serious infections
  • Known hypersensitivity to 5-fluorouracil
  • Known or suspected dihydropyrimidine dehydrogenase deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Q

Quynh Nhu Nguyen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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