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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07700420
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

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

Interventions

  • PULSAR- Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy — RADIATION
    -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
  • FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)(D) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2031

Study Design

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

Arms

  • Experimental: PULSAR radiation in combination with perioperative FLOT(D)
    PULSAR radiation plus FLOT(D) Each cycle of FLOT(D) consists of 5-fluorouracil 2600 mg/m2 administered over 24 hours, leucovorin 200 mg/m2 administered over 2 hours, oxaliplatin 85 mg/m2 administered over 2 hours and docetaxel 50 mg/m2 administered over 1 hour. All medications are administered intravenously via mediport. Durvalumab 1500 mg will be administered intravenously over 1 hour according to the usual q4 week schedule - with every other chemo cycle. On completion of adjuvant chemotherapy.

Primary Outcome Measure

Recommended phase 2 dose (RP2D) of PULSAR [ Time Frame: First administration of radiotherapy (RT) to 60 days after completion of RT or day of surgery, whichever occurs first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Jennifer Knight
[email protected]
214-648-7097

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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