Preoperative Hypofractionated Radiotherapy with FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

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.

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

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Study Overview

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Study Details

Study overview

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.

Preoperative Hypofractionated Radiotherapy with FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)

Preoperative Hypofractionated Radiotherapy with FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Condition
Clinical Stage I Esophageal Adenocarcinoma AJCC V8
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 chemotherapy, 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

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

Study Record Dates

2026-11-30