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PULSAR Radiation with FLOT(D) Chemotherapy for Esophageal and GEJ Cancer

This study is testing a new way to treat esophageal and gastroesophageal junction (GEJ) cancer. It combines standard chemotherapy (FLOT or FLOT(D), which includes 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) and immunotherapy (Durvalumab) with a special type of radiation called PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy). The main goal is to find the safest dose of PULSAR radiation when added to these standard treatments. You can join if you are at least 18 years old and have been diagnosed with esophageal or GEJ adenocarcinoma. The study is currently unclear about its recruitment status, but it plans to enroll 15 participants.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive standard chemotherapy and immunotherapy, along with PULSAR radiation. There will be additional visits and assessments related to the radiation treatment.
Compensation
Not stated in the trial record.
Follow-up
All patients will enter follow-up on completion of FLOT chemotherapy. The primary endpoint measures safety up to 60 days after radiation or surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07700420

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~15 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:PULSAR- Personalized Ultra-fractionated Stereotactic Ablative RadiotherapyFLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose (RP2D) of PULSAR
Measured over First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first

Conditions

Gastro-esophageal Junction (GEJ) Cancer
Esophagus Cancer

Explore related trials

Esophageal AdenocarcinomaGastroesophageal Junction Adenocarcinoma

NCT07700420

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Jennifer Knight
[email protected]
214-648-7097
Email the study team

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Eligibility criteria

Inclusion

Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

What this trial measures

  • Recommended phase 2 dose (RP2D) of PULSARFirst administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first

    To determine the recommended phase 2 dose (RP2D) of PULSAR that produces a Dose-Limiting Toxicity (DLT) rate of 30% when interdigitated with perioperative FLOT(D) chemotherapy. The RP2D of PULSAR will be determined by toxicity assessed by NCI CTCAE v5.0 toxicity criteria