Actively Recruiting
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma (PHOX)
Led by Mayo Clinic · Updated on 2026-04-20
99
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new preoperative treatment combining hypofractionated radiation therapy with chemotherapy drugs fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) for patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma. This phase II trial aims to test whether this shorter, higher-dose radiation approach combined with chemotherapy can kill more tumor cells and reduce side effects. The study also compares outcomes with historical data and explores various effects including survival, toxicity, and quality of life. Participants first receive induction chemotherapy with a combination of 5-FU, leucovorin calcium, oxaliplatin, and docetaxel (FLOT), with some also receiving durvalumab. Following this, they undergo a three-week course of daily radiation therapy combined with two cycles of FOLFOX chemotherapy. The study involves several procedures including esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), CT and PET scans, and blood and tissue sample collection for research. Throughout the study, participants are closely monitored with follow-up visits at 6, 12, and 24 months, and then up to 5 years. Researchers assess tumor response, side effects, quality of life, financial impact, survival, and long-term toxicity. The study also evaluates differences in toxicity between proton and photon radiation therapies and investigates biomarkers to predict treatment response and personalize future therapies.
CONDITIONS
Brief Title
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Histological confirmation of 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 by surgical consultation
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test 64 7 days prior to chemotherapy for women of childbearing potential
- Ability to provide written informed consent and complete questionnaires
- Willing to return for follow-up during active monitoring phase
- Willing to provide blood and tissue samples for research
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 thorax radiotherapy history
- Severe concurrent disease or systemic illness that interferes with study participation or assessment
- Receiving investigational agents for cancer or other malignancy within 1 year prior to registration if interfering with treatment or outcomes
- Pregnant or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive up to 6 cycles of chemotherapy with 5-FU, leucovorin, oxaliplatin, and docetaxel every 2 weeks, with some receiving durvalumab every 4 weeks.
Up to 6 chemotherapy visits every 2 weeks and additional durvalumab visits every 4 weeks
Duration - 3 weeks for radiation with 6 weeks of chemotherapy
Participants receive hypofractionated radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX chemotherapy repeated every 2 weeks.
Daily radiation visits Monday through Friday for 3 weeks and 3 chemotherapy cycles every 2 weeks
Duration - Up to 5 years
Participants are followed up to monitor outcomes including survival, toxicity, and quality of life after completion of treatment.
Visits at 6, 12, and 24 months, then yearly up to 5 years
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
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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