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Chemotherapy with or without radiation or surgery for oligometastatic esophageal or gastric cancer

This study is looking at how well chemotherapy, with or without radiation or surgery, works for people with esophageal or gastric cancer that has spread to a few (three or less) other places in the body (oligometastatic). You would receive induction chemotherapy first. Then, you would either continue with maintenance chemotherapy using fluorouracil and capecitabine, or you would receive fluorouracil and capecitabine along with radiation therapy and potentially surgery. The study aims to see if adding radiation and surgery improves how long people live (overall survival). You can join if you are between 18 and 79 years old and have been diagnosed with adenocarcinoma of the esophagus or stomach with three or fewer metastatic lesions.

Study design
This is an interventional study with a planned enrollment of 100 participants. After initial chemotherapy, participants are randomly assigned to one of two groups.
What's involved
You would receive induction chemotherapy for 6 to 8 cycles. Then, depending on your assigned group, you would continue with maintenance chemotherapy, or receive maintenance chemotherapy along with radiation therapy and possibly surgery.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03161522

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

Recruiting
PHASE2Ages 18–79InterventionalTreatment
M.D. Anderson Cancer Center
~100 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:CapecitabineChemotherapyConventional SurgeryFluorouracilRadiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to 6 years

Conditions

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

Explore related trials

Esophageal AdenocarcinomaGastric Adenocarcinoma

NCT03161522

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Quynh Nhu Nguyen, MD
[email protected]
713-563-2300
Email the study team

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Eligibility criteria

Inclusion

The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
The patient is staged with EGD and PET/CT scan.
The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT).
The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion).
Osseous metastases or visceral metastases will each count as one metastatic site.
Each CNS metastases will count as one metastatic site.
Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation.
Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment.
Patient ECOG of 0-2, with life expectancy of at least 6 months
Patients age \>18 yrs old but \<80 yrs old and signed informed consent
Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents.

Exclusion

Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized.
Patients with fistula documented radiographically or by EDG/EUS, EBUS.
Patients with life expectancy less than 6 months, ECOG \>3
Female patients who are pregnant confirmed by bHCG lab test.
Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months.
Nursing females
Patients in poor nutritional state
Patients with:
Severely depressed bone marrow function
Potentially serious infections
Known hypersensitivity to 5-fluorouracil
Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

What this trial measures

  • Overall survival (OS)Up to 6 years

    OS distributions in the two arms will be estimated by the method of Kaplan and Meier. Bayesian piecewise exponential regression will be used to assess the relationships between each of OS and PFS, and patients' covariates and treatment arm.