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Radiation and FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

This study is testing a new way to treat stage I-III esophageal or gastroesophageal junction adenocarcinoma (a type of cancer in the esophagus or where the esophagus meets the stomach). It's looking at how well radiation therapy, given in higher doses over a shorter time (hypofractionated radiotherapy), works when combined with the chemotherapy drugs fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) before surgery. Fluorouracil helps kill cancer cells, and leucovorin helps fluorouracil work better. The study aims to see if this treatment is as effective as current standard treatments in completely getting rid of the cancer before surgery. It will also look at side effects and quality of life for the 99 participants.

Study design
This is an interventional study with a planned enrollment of 99 participants. It is testing a specific treatment approach.
What's involved
You would undergo blood sample collection, CT and PET/CT scans, endoscopic ultrasound (EUS), and esophagogastroduodenoscopy (EGD). You would also receive fluorouracil intravenously.
Compensation
Not stated in the trial record.
Follow-up
The main success of the treatment will be measured up to 5 years after the chemoradiation is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06078709

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~99 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyEndoscopic UltrasoundEsophagogastroduodenoscopyFluorouracilHypofractionated Radiation Therapy

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic complete response
Measured over Up to 5 years after completion of chemoradiation

Conditions

Clinical Stage I Esophageal Adenocarcinoma AJCC v8
Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8

Explore related trials

Esophageal AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT06078709

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Arizona

    Scottsdale, Arizonastudy coordinator listed

    Not yet recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Floridano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christopher L. Hallemeier, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years
Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0
Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy
Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only
Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to provide blood and tissue samples for correlative research purposes

Exclusion

Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)
Cervical or upper esophageal tumor
Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events
Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes
Any of the following:
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception

What this trial measures

  • Pathologic complete responseUp to 5 years after completion of chemoradiation

    A single-group design will be used to test whether the proportion is potentially non-inferior, with a non-inferiority proportion (P0) of 0.13 (H0: P ≤ 0.13 versus H1: P \> 0.13).