Preoperative radiation therapy with FOLFOX for esophageal cancer
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
This study is testing a new combination of radiation and chemotherapy before surgery to see if it helps people with esophageal cancer feel better and have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation, durvalumab, immunotherapy |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06078709 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of preoperative hypofractionated radiation therapy combined with the chemotherapy regimen FOLFOX for patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma. The study aims to demonstrate that this treatment approach can achieve a pathologic complete response comparable to historical controls while assessing the associated toxicities and patient quality of life. Participants will undergo a series of assessments, including toxicity evaluations and survival analyses, to determine the overall impact of this treatment strategy. Additionally, the study will explore the role of circulating tumor DNA and genetic sequencing in predicting treatment response and toxicity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed stage I-III esophageal or gastroesophageal junction adenocarcinoma who are suitable for trimodality therapy.
Not a fit: Patients with distant metastatic disease or those who are not candidates for esophagectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce side effects for patients with esophageal cancer.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of hypofractionated radiotherapy and FOLFOX is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Not_yet_recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Active_not_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Christopher L. Hallemeier, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.