NCT06078709RecruitingPhase 2
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 25 May 2029
- Lead sponsor
- Mayo Clinic
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06078709
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 99
- From 21 Nov 2023 to the primary completion date, 25 May 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)
Other
- Cervical or upper esophageal tumor
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Active, not recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.