Induction Chemotherapy for Locally Advanced Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Jun 24, 2021
  • participants needed
    40
  • sponsor
    University of Rochester
Updated on 24 January 2021
platelet count
cancer
fluorouracil
squamous cell carcinoma
oxaliplatin
chemoradiotherapy
esophageal cancer
leucovorin
adenocarcinoma

Summary

Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.

Description

The goal of the study is to evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer. mFOLFOX6 is frequently used to treat metastatic esophageal cancer because of its high response rate in this setting. It has shown promising efficacy in several trials of patients with advanced esophageal cancer and it is the most commonly used combination regimen for this group of patients in the United States.

The investigators propose treating a sample of 40 patients with 3 cycles of induction mFOLFOX6 chemotherapy over six weeks followed by standard chemoradiation and surgery. The investigators hypothesize that patients who undergo induction chemotherapy with mFOLFOX6 prior to standard neoadjuvant chemoradiation and surgery will have a lower rate of distant disease recurrence compared to standard neoadjuvant chemoradiation and surgery.

Details
Condition Esophageal Carcinoma, cancer of the esophagus, oesophageal carcinoma
Treatment mFOLFOX6, Chemoradiation
Clinical Study IdentifierNCT03110926
SponsorUniversity of Rochester
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Esophageal Carcinoma?
Do you have any of these conditions: oesophageal carcinoma or cancer of the esophagus or Esophageal Carcinoma?
Must have histologically proven adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the esophagus, GE junction and/or gastric cardia
Must have potentially resectable disease
Must have ECOG performance status 0 or 1
Must have adequate organ function as defined by the following criteria
ANC 1,500/mm3
Platelet count 100,000/mm3
Creatinine (Cr) 1.5 mg and/or creatinine clearance 60cc/min
Total bilirubin must be 1.5 x ULN unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin
Alkaline phosphatase must be 2 x ULN
AST & ALT must be 3 x ULN
Men and women of reproductive potential must agree to use an effective contraception method
Must be willing and able to provide written informed consent
Must be 18 years or older

Exclusion Criteria

Prior chemotherapy, thoracic radiotherapy or prior surgical resection for an esophageal tumor
Known distant metastases
Patients with prior malignancies are eligible if they have been disease-free for > 5 years and are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization
Known grade 2 neuropathy
Known non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs
Known psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements
Women who are pregnant or nursing
Women and men of reproductive potential who are expecting to conceive or father children
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