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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03161522
Phase
PHASE2
Status
Recruiting
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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 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
  • Chemotherapy — DRUG
    Receive induction chemotherapy
  • Conventional Surgery — PROCEDURE
    Undergo surgery
  • Fluorouracil — DRUG
    Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
  • Radiation Therapy — RADIATION
    Undergo RT

Study Details

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.

Key Dates

Start date
Feb 19, 2018
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Quynh-Nhu Nguyen
713-563-2300
Quynh-Nhu Nguyen (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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