RECRUITING

Preoperative Hypofractionated Radiotherapy with FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Preoperative Hypofractionated Radiotherapy with FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)

Quick Facts

Study Start:2023-11-20
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06078709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0
  3. * Candidate for trimodality therapy: neoadjuvant chemotherapy, chemoradiation, and esophagectomy
  4. * Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy
  5. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  6. * Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only
  7. * Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance
  8. * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  9. * Willing to provide blood and tissue samples for correlative research purposes
  1. * Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)
  2. * Cervical or upper esophageal tumor
  3. * Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax
  4. * 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
  5. * 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
  6. * Any of the following:
  7. * Pregnant women
  8. * Nursing women
  9. * Men or women of childbearing potential who are unwilling to employ adequate contraception

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Christopher L. Hallemeier, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Christopher L. Hallemeier, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2023-11-20
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical Stage I Esophageal Adenocarcinoma AJCC V8
  • Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC V8
  • Clinical Stage II Esophageal Adenocarcinoma AJCC V8
  • Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC V8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC V8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC V8