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NCT06078709 · ClinicalTrials.gov registry record · Phase 2

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
99
Enrollment target
3
Study locations

NCT06078709: Recruiting Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by Mayo Clinic.

NCT06078709 is a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 99 participants, roughly in line with the 93-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06078709, a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
99 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

A single-group design will be used to test whether the proportion is potentially non-inferior, with a non-inferiority proportion (P0) of 0.13 (H0: P ≤ 0.13 versus H1: P \> 0.13).

Conditions Studied

Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage I Esophageal Adenocarcinoma AJCC v8 Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • PROCEDURE Endoscopic Ultrasound
  • PROCEDURE Esophagogastroduodenoscopy

Study Locations (3)

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Florida

  • Mayo Clinic in Florida - Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2023-11-20
Est. Completion 2031-05-30
Phase Phase 2
Mayo Clinic

2,844 total trials

What NCT06078709 shows while recruiting

NCT06078709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, roughly in line with the 93-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target.

The record links to 6 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06078709 reports a single indexed study location in Arizona, Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT06078709 about?

NCT06078709 is a clinical study titled "Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma". 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...

What is the current status of trial NCT06078709?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2023-11-20. Estimated completion is 2031-05-30.

What conditions does trial NCT06078709 study?

This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Adenocarcinoma AJCC v8.

What interventions are being tested in trial NCT06078709?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Endoscopic Ultrasound (PROCEDURE), Esophagogastroduodenoscopy (PROCEDURE).

Who is sponsoring clinical trial NCT06078709?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06078709 being conducted?

This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06078709's enrollment target sits among peer trials

99 7th of 19 higher than 13 of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06078709

Source: ClinicalTrials.gov NCT06078709, the US trial registry maintained by the National Library of Medicine. NCT06078709 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.