Health Trials

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

ConditionsClinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Endoscopic Ultrasound
  • Esophagogastroduodenoscopy
  • Fluorouracil
  • Hypofractionated Radiation Therapy
  • Leucovorin Calcium
  • Oxaliplatin
  • Positron Emission Tomography
  • Survey Administration
  • Docetaxel
  • Durvalumab

Treatment groups

99 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov