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Perioperative FLOT(D) With Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) in Esophageal Cancer

NCT07700420 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-07-14

No results posted yet for this study

Summary

The goal of this clinical trial is to learn the safety of the addition of PULSAR radiation to standard of care chemotherapy and immunotherapy in people with esophageal and gastroesophageal junction cancer and to determine the safest dose of radiation that can be used.

Participants in this study will be undergoing clinically scheduled procedures. In addition to the standard of care visits and treatments, there will be additional visits and assessments with radiation.

Conditions

  • Gastro-esophageal Junction (GEJ) Cancer
  • Esophagus Cancer

Interventions

RADIATION

PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy

-1 5.5 Gy x 4 Fractions 1. 6 Gy x 4 Fractions 2. 6 Gy x 4 Fractions with simultaneous boost to gross disease to 7 Gy x 4 Fractions 3. 6 Gy x 4 Fractions with simultaneous boost to gross disease to 8 Gy x 4 Fractions

DRUG

FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)

5-fluorouracil 2600 mg/m2 leucovorin 200 mg/m2 ad oxaliplatin 85 mg/m2 docetaxel 50 mg/m2 Durvalumab 1500 mg All medications are administered intravenously via mediport.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Timothy Brown, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-10-01
Completion
2031-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700420 on ClinicalTrials.gov