Actively Recruiting
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Led by Mayo Clinic · Updated on 2026-04-20
99
Participants Needed
3
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed esophageal or gastroesophageal junction adenocarcinoma, AJCC 8th edition stage T1-4N0-3M0
- Candidate for trimodality therapy including neoadjuvant chemo(immuno)therapy, chemoradiation, and esophagectomy
- Confirmed appropriate candidate for esophagectomy after surgical consultation
- ECOG performance status 0 or 1
- Negative pregnancy test within 7 days before chemotherapy for women of childbearing potential
- Ability to provide written informed consent and complete questionnaires alone or with assistance
- Willingness to return to the enrolling institution for follow-up during active monitoring
- Willingness to provide blood and tissue samples for research purposes
You will not qualify if you...
- 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 thoracic radiotherapy
- Severe systemic illnesses or concurrent diseases that interfere with study participation or adverse event assessment
- Receiving investigational agents for primary or other active malignancies within one year prior to registration that interfere with treatment or outcome measurement
- Pregnant women
- Nursing women
- Men or women of childbearing potential unwilling to use adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Active, Not Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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