RecruitingPhase 2NCT06906887

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

Sponsor

Medical College of Wisconsin

Enrollment

50 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastroesophageal Cancer Oesophageal Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new way of delivering radiation — in pulses at lower doses — combined with chemotherapy for esophageal (food pipe) cancer, to see if it works as well or better than standard chemoradiation with fewer side effects. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage II–IVb esophageal cancer (adenocarcinoma type) - You are currently receiving or have received induction chemotherapy and are planned for chemoradiation - You are in reasonably good physical condition (able to carry out daily activities) - Your blood counts and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has widely spread and is not considered eligible for definitive chemoradiation - Your blood cell counts or kidney function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInduction Chemotherapy (modified FLOT or modified FOLFOX-6)

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.

DRUGChemotherapy

The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.

RADIATIONConventional Radiation

RADIATIONPulsed Low-Dose-Rate (PLDR) 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.

PROCEDURESurgery

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.