RecruitingPhase 2NCT03161522

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

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

Feb 19, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different treatment approaches — chemotherapy alone, or chemotherapy combined with surgery or radiation — for people with cancer of the esophagus (food pipe) or stomach that has spread to a limited number of other areas in the body. **You may be eligible if...** - You have been diagnosed with esophageal or stomach cancer confirmed by a tissue sample - Your cancer has spread to 3 or fewer sites in the body - You have had imaging scans (PET/CT) to stage your cancer - Your tumor meets certain size requirements **You may NOT be eligible if...** - Your cancer has spread to more than 3 sites - You are not well enough to tolerate treatment - You do not meet specific imaging or staging requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

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

DRUGChemotherapy

Receive induction chemotherapy

PROCEDUREConventional Surgery

Undergo surgery

DRUGFluorouracil

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

RADIATIONRadiation Therapy

Undergo RT


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03161522


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