Actively Recruiting
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
Led by Medical College of Wisconsin · Updated on 2025-06-29
50
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stage II to IVb adenocarcinoma of the esophagus (IVb allowed if limited metastases and suitable for definitive chemoradiation)
- Receiving or planned for definitive chemoradiation, with or without esophagectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood counts within 30 days prior to registration: Absolute Neutrophil Count ≥ 1,500/mcg, Hemoglobin ≥ 8 gm/dL, Platelets ≥ 100,000/mcL
- Adequate kidney function with creatinine clearance ≥ 50 ml/min within 30 days prior to registration
- Adequate liver function with total bilirubin ≤ 1.5 times the upper limit of normal (ULN); patients with Gilbert Syndrome can have bilirubin < 2.5 x ULN
- Female patients under 65 years of age and of childbearing potential must have a negative pregnancy test within 14 days prior to study entry
- Patients of reproductive potential must agree to use effective contraception during the study treatment
- Patients with prior or concurrent cancers that do not interfere with safety or efficacy assessments
- Ability and willingness to understand and sign informed consent
You will not qualify if you...
- Age younger than 18 years
- Extensive distant metastatic cancer with more than 5 metastases
- Recurrent esophageal cancer
- Prior chemotherapy not approved for the cancer treatment
- Previous radiation overlapping the study cancer region
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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