Recruiting
Phase 2

FOLFOX with Hypofractionated Radiation

Sponsor:

Mayo Clinic

Code:

NCT06078709

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Endoscopic Ultrasound

Esophagogastroduodenoscopy

Fluorouracil

Study Details

Brief summary:

This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.

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

Study ID

NCT06078709

Start date

Nov 20, 2023

Status verified date

Apr, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

99 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (FLOT and Radiation and FOLFOX)

Patients received Induction Chemotherapy \[FLOT (5-FU/leucovorin/oxaliplatin/docetaxel)\] following by radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX per protocol. See detailed description for more information.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT and PET/CT scan

Endoscopic Ultrasound

Undergo EUS

Esophagogastroduodenoscopy

Undergo EGD

Fluorouracil

Given IV

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Leucovorin Calcium

Given IV

Oxaliplatin

Given IV

Positron Emission Tomography

Undergo PET and PET/CT scan

Survey Administration

Ancillary studies

Docetaxel

Given IV

Durvalumab

Given IV

Primary outcome measure

  • Pathologic complete response [ Time Frame: Up to 5 years after completion of chemoradiation ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Christopher L. Hallemeier, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-20.