NCT06078709 Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
| NCT ID | NCT06078709 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Clinical Stage I Esophageal Adenocarcinoma AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2023-11-20 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 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 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
Contact & Investigator
Christopher L. Hallemeier, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06078709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clinical Stage I Esophageal Adenocarcinoma AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06078709 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06078709 currently recruiting?
Yes, NCT06078709 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06078709 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Rochester, United States.
Who is sponsoring the NCT06078709 clinical trial?
NCT06078709 is sponsored by Mayo Clinic. The principal investigator is Christopher L. Hallemeier, MD at Mayo Clinic in Rochester. The trial plans to enroll 99 participants.