PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06906887
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Induction Chemotherapy (modified FLOT or modified FOLFOX-6) — DRUG
    Subjects are expected to receive 2-4 months of induction chemotherapy; the interval and dosages will be determined and can be modified at the discretion of their medical oncologist. The preferred induction chemotherapies are modified FLOT or FOLFOX-6. Subjects can enroll if they receive less than 2 months of induction chemotherapy as long as they are deemed to be a candidate for concurrent chemoradiation therapy.
  • Chemotherapy — DRUG
    The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.
  • Conventional Radiation — RADIATION
    For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment.
  • Pulsed Low-Dose-Rate (PLDR) Radiation — RADIATION
    For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment. For PLDR radiation therapy, each fraction will be delivered as a series of 20 cGy (or 0.2 Gy) pulses that are separated by 3-minute time intervals.
  • Surgery — PROCEDURE
    Esophagectomy is not required for trial and will be administered per medical judgement of the treating physicians. Surgery will take place at the time directed by the surgeon. This typically will take place approximately 6-13 weeks after chemoradiation therapy.

Study Details

This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.

Key Dates

Start date
Jun 17, 2025
Status verified
Jun 2025
Primary completion
Nov 1, 2030
Completion
Jun 1, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed Low-Dose-Rate Radiation (PLDR)
    Neoadjuvant radiation delivered in short pulses; same dose as standard chemoradiation arm.
  • Experimental: Standard Chemoradiation
    Standard (non-pulsed) neoadjuvant radiation; same dose as PLDR arm.

Primary Outcome Measure

New prescription for narcotics [ Time Frame: Up to 6 weeks after radiation treatment ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Lindsay Puckett, MD
[email protected]
414-805-4400
Lindsay Puckett, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milwaukee, WI

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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