RECRUITING Phase 2 ClinicalTrials.gov

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT06078709

Registry updated: 2026-10-01

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Description

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.

Interventions

Biospecimen Collection (Procedure)
Undergo blood sample collection
Computed Tomography (Procedure)
Undergo CT and PET/CT scan
Endoscopic Ultrasound (Procedure)
Undergo EUS
Esophagogastroduodenoscopy (Procedure)
Undergo EGD
Fluorouracil (Drug)
Given IV
Hypofractionated Radiation Therapy (Radiation)
Undergo hypofractionated radiation therapy
Leucovorin Calcium (Drug)
Given IV
Oxaliplatin (Drug)
Given IV
Positron Emission Tomography (Procedure)
Undergo PET and PET/CT scan
Survey Administration (Other)
Ancillary studies
Docetaxel (Drug)
Given IV
Durvalumab (Biological)
Given IV

Eligibility criteria

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

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

Locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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