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New chemo combo aims to stop esophageal cancer from coming back

NCT ID NCT03110926

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This phase II trial is testing whether giving a chemotherapy combination called mFOLFOX6 before the usual chemoradiation and surgery can help prevent esophageal cancer from returning. The study involves 40 adults with locally advanced esophageal cancer that can be surgically removed. Researchers are measuring how many patients remain cancer-free after two years and checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mFOLFOX6 (a combination of chemotherapy drugs: oxaliplatin, leucovorin, and 5-fluorouracil)
What this could lead to
If successful, this approach could lower the chance of cancer returning after standard treatment for locally advanced esophageal cancer.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. Chemotherapy can cause significant side effects, and the added benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2017

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must have histologically proven adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the esophagus, GE junction and/or gastric cardia. 2. Must have potentially resectable disease. 3. Must have ECOG performance status 0 or 1. 4. 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. 5. Men and women of reproductive potential must agree to use an effective contraception method 6. Must be willing and able to provide written informed consent 7. Must be ≥ 18 years or older Exclusion Criteria: 1. Prior chemotherapy, thoracic radiotherapy or prior surgical resection for an esophageal tumor. 2. Known distant metastases. 3. 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. 4. Known ≥ grade 2 neuropathy. 5. Known non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs. 6. Known psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements. 7. Women who are pregnant or nursing. 8. Women and men of reproductive potential who are expecting to conceive or father children.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Rochester

    Rochester, New York, 14642, United States

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