Recruiting
Phase 2

Chemotherapy with Radiation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03161522

Conditions

Gastric Adenocarcinoma

Oligometastasis

Stage IV Esophageal Adenocarcinoma AJCC v7

Stage IV Esophageal Cancer AJCC v7

Stage IV Gastric Cancer AJCC v7

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Capecitabine

Chemotherapy

Conventional Surgery

Fluorouracil

Radiation Therapy

Study Details

Brief 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

Study ID

NCT03161522

Start date

Feb 19, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (maintenance chemotherapy)

Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.

experimental: Group II (local therapy)

Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.

Interventions

Capecitabine

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

Chemotherapy

Receive induction chemotherapy

Conventional Surgery

Undergo surgery

Fluorouracil

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

Radiation Therapy

Undergo RT

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Quynh Nhu Nguyen, MD

713-563-2300qnnguyen@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Quynh-Nhu Nguyen

713-563-2300

Principal Investigator:

Quynh-Nhu Nguyen

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.