New chemo combo aims to stop esophageal cancer from coming back
NCT ID NCT03110926
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
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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