Induction Chemotherapy for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRichard Dunne, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Rochester

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with locally advanced esophageal cancer that can potentially be removed by surgery. They must have good organ function, no prior treatments for esophageal cancer, not be pregnant or planning to become pregnant, and have no serious non-cancer illnesses or neuropathy.

Inclusion Criteria

My blood tests show my organs are functioning well.

My disease can possibly be removed with surgery.

I am fully active or restricted in physically strenuous activity but can do light work.

+4 more

Exclusion Criteria

I have moderate to severe nerve damage.

I've been cancer-free for over 5 years or had certain skin or in situ cancers treated effectively.

I do not have any chronic diseases that would interfere with the study's treatment.

+5 more

Participant Groups

The study tests if adding mFOLFOX6 chemotherapy before the usual chemoradiation treatment improves outcomes in patients with advanced esophageal cancer. It aims to reduce the chance of the cancer spreading elsewhere in the body.

1Treatment groups

Experimental Treatment

Group I: Induction Chemotherapy /ChemoradiationExperimental Treatment2 Interventions

mFOLFOX6 for 3 cycles - Oxaliplatin 85 mg/m2, 5-fluorouracil 2400mg/m2/46 hours, 5-fluorouracil bolus 400mg/m2 and leucovorin 400 mg/m2, then chemoradiation for 5 cycles - Carboplatin AUC 2mg/mL/min, Paclitaxel 50 mg/m2 and radiation therapy.

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: