RecruitingPhase 2NCT06078709

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

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


Sponsor

Mayo Clinic

Enrollment

99 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Computed Tomography, and others for people with clinical stage i esophageal adenocarcinoma ajcc v8, clinical stage i gastroesophageal junction adenocarcinoma ajcc v8, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT and PET/CT scan

PROCEDUREEndoscopic Ultrasound

Undergo EUS

PROCEDUREEsophagogastroduodenoscopy

Undergo EGD

DRUGFluorouracil

Given IV

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

DRUGLeucovorin Calcium

Given IV

DRUGOxaliplatin

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET and PET/CT scan

OTHERSurvey Administration

Ancillary studies

DRUGDocetaxel

Given IV

BIOLOGICALDurvalumab

Given IV


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06078709


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