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Anti-metabolites

Induction Chemotherapy for Esophageal Cancer

Phase 2

Waitlist Available

Led By Richard Dunne, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have ECOG performance status 0 or 1

Must have adequate organ function: 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

Must not have

Known ≥ grade 2 neuropathy

Known non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new chemotherapy regimen to see if it can decrease the rate of cancer recurrence.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

mFOLFOX6 may cause side effects like nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems, nerve damage (neuropathy), and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My blood tests show my organs are functioning well.

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My cancer is confirmed to be in the esophagus, GE junction, or gastric cardia.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage.

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

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I am not pregnant or nursing.

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My cancer has spread to distant parts of my body.

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I have had chemotherapy, radiotherapy, or surgery for esophageal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival rate

Secondary study objectives

Overall disease-free survival

Overall survival

Pathologic examination

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Leucovorin

FDA approved

0 / 9Eligibility criteria met