Actively Recruiting
PULSO Trial: Pulsed Low-Dose-Rate Radiation Chemoradiation versus Standard Chemoradiation for Esophageal Cancer
Led by Medical College of Wisconsin · Updated on 2025-06-29
50
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a treatment approach for locally advanced esophageal cancer to see if Pulsed Low-Dose-Rate (PLDR) radiation combined with chemotherapy can lower the chance of serious esophagus inflammation (esophagitis) compared to standard radiation with chemotherapy. This phase 2 trial is randomized and open-label, focusing on whether PLDR radiation causes fewer side effects during and after chemoradiation. The trial aims to improve treatment while maintaining effectiveness for esophageal cancer. Participants receive induction chemotherapy, typically modified FLOT or FOLFOX-6, for 2 to 4 months before starting radiation. They then undergo either PLDR radiation, delivered in low-dose pulses with timed pauses, or standard radiation, both given with concurrent chemotherapy (carboplatin and paclitaxel weekly). Radiation doses are similar in both groups, and surgery (esophagectomy) may occur about 6 to 13 weeks after chemoradiation if recommended by the doctor. During the study, participants will have assessments of pain management needs, including new or increased prescriptions for narcotics, and their ability to eat by mouth during and up to six weeks after radiation treatment. Researchers will monitor side effects, treatment effects, and overall health through exams and lab tests. The trial involves regular evaluations to compare the impact of the two radiation methods on treatment tolerability and quality of life for up to six weeks after therapy.
CONDITIONS
Brief 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 only if limited metastases and eligible for definitive chemoradiation)
- Currently receiving or have received induction chemotherapy and planned for definitive chemoradiation with or without esophagectomy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate blood counts within 30 days before 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 before registration
- Adequate liver function with total bilirubin ≤ 1.5 times upper limit of normal (ULN) within 30 days before registration; patients with Gilbert Syndrome allowed bilirubin < 2.5 x ULN
- Female patients under 65 years 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 study treatment
- Patients with prior or concurrent malignancies are eligible if these do not interfere with safety or efficacy assessments
- Ability to understand and sign informed consent
You will not qualify if you...
- Age under 18 years
- Extensive distant metastatic cancer with more than 5 metastases
- Recurrent esophageal cancer (prior or concurrent malignancies allowed if not impacting study's primary endpoint)
- Prior chemotherapy for cancer treatment not approved by the study
- Prior radiation therapy overlapping the study cancer region
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 months
Participants receive 2 to 4 months of induction chemotherapy with modified FLOT or modified FOLFOX-6 regimens before starting chemoradiation.
Visits as determined by the medical oncologist during chemotherapy
Duration - Approximately 5 weeks (23 to 28 radiation fractions)
Participants receive weekly chemotherapy with carboplatin and paclitaxel combined with either pulsed low-dose-rate radiation therapy or standard conventional radiation therapy.
Weekly visits for chemoradiation treatment
Duration - Single surgery event with recovery period
Some participants may undergo esophagectomy approximately 6 to 13 weeks after completing chemoradiation, based on physician judgment.
1 to 2 visits depending on surgical scheduling and recovery
Duration - Up to 6 weeks after radiation treatment
Participants are monitored for up to 6 weeks after radiation treatment to assess pain management, narcotic use, and oral intake.
Approximately 6 post-treatment visits
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
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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