Preoperative radiation therapy with FOLFOX for esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Not yet recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Active not 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.