Study on Induction Chemotherapy for Locally Advanced Esophageal Cancer

Sponsor: University of Rochester

Sponsor score: 0

ClinicalTrials ID:NCT03110926

Provider View

This clinical trial is testing whether adding a chemotherapy treatment called mFOLFOX6 before the usual chemoradiation and surgery can help reduce the chance of esophageal cancer coming back in other parts of the body.

Patient Parameters

Program Overview

The study aims to find out if using a chemotherapy treatment called mFOLFOX6 before the standard treatment of chemoradiation and surgery can lower the risk of esophageal cancer spreading to other areas. mFOLFOX6 is a combination of three drugs: 5-Fluorouracil, Leucovorin, and Oxaliplatin, which are often used to treat advanced esophageal cancer. Researchers will treat 40 patients with this chemotherapy for six weeks, followed by the usual treatment, to see if it helps prevent the cancer from returning.

Description

This study is testing a chemotherapy treatment called mFOLFOX6, which includes the drugs 5-Fluorouracil, Leucovorin, and Oxaliplatin, to see if it can help prevent esophageal cancer from spreading to other parts of the body. mFOLFOX6 is already used to treat advanced esophageal cancer because it works well in many cases. In this study, 40 patients will receive three cycles of mFOLFOX6 over six weeks before undergoing the standard treatment of chemoradiation and surgery. Researchers believe that starting with mFOLFOX6 might lower the chances of the cancer coming back compared to just using the standard treatment alone.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of adenocarcinoma, squamous cell carcinoma, or undifferentiated carcinoma of the esophagus, gastroesophageal junction, or gastric cardia.
  • The cancer must be potentially removable by surgery.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function, including:
    • Neutrophil count of at least 1,500/mm3.
    • Platelet count of at least 100,000/mm3.
    • Creatinine level of 1.5 mg or lower, or creatinine clearance of 60cc/min or higher.
    • Total bilirubin level of 1.5 times the upper limit of normal or lower, unless due to a known condition like Gilbert's disease.
    • Alkaline phosphatase level of 2 times the upper limit of normal or lower.
    • AST and ALT levels of 3 times the upper limit of normal or lower.
  • Agree to use effective contraception if of reproductive potential.
  • Be willing and able to provide written informed consent.
  • Be 18 years or older.

Exclusion Criteria

  • Have had previous chemotherapy, radiation therapy to the chest, or surgery for esophageal cancer.
  • Have known cancer spread to distant parts of the body.
  • Have had other cancers unless they have been disease-free for more than 5 years and are considered low risk for recurrence. Exceptions include certain skin cancers and in situ cancers that have been effectively treated.
  • Have known nerve damage of grade 2 or higher.
  • Have serious non-cancerous diseases that would prevent the use of study drugs.
  • Have psychiatric or addiction issues that would prevent meeting study requirements.
  • Be pregnant or nursing.
  • Plan to conceive or father children during the study.

Locations

FACILITYZIPCITYSTATE
University of Rochester14642RochesterNew York

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