Overview

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Status:
Recruiting
Trial end date:
2026-11-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Calcium
Calcium, Dietary
Fluorouracil
Folic Acid
Leucovorin
Levoleucovorin
Oxaliplatin
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 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 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