Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06078709
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT scan
  • Endoscopic Ultrasound — PROCEDURE
    Undergo EUS
  • Esophagogastroduodenoscopy — PROCEDURE
    Undergo EGD
  • Fluorouracil — DRUG
    Given IV
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated radiation therapy
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET and PET/CT scan
  • Survey Administration — OTHER
    Ancillary studies
  • Docetaxel — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Nov 20, 2023
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
99 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FLOT and Radiation and FOLFOX)
    Patients received Induction Chemotherapy \[FLOT (5-FU/leucovorin/oxaliplatin/docetaxel)\] following by radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX per protocol. See detailed description for more information.

Primary Outcome Measure

Pathologic complete response [ Time Frame: Up to 5 years after completion of chemoradiation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Jonathan B. Ashman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Christopher L. Hallemeier, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

Related Studies