PULSO Trial: Comparing Pulsed Low-Dose-Rate Radiation with Standard Radiation for Esophageal Cancer

Sponsor: Medical College of Wisconsin

Sponsor score: 0

ClinicalTrials ID:NCT06906887

Provider View

This study is testing a new radiation technique called Pulsed Low-Dose-Rate (PLDR) radiation to see if it causes less esophagitis, a painful inflammation of the esophagus, compared to standard radiation when used with chemotherapy for esophageal cancer.

Patient Parameters

Program Overview

The PULSO trial is exploring whether a new radiation method, Pulsed Low-Dose-Rate (PLDR) radiation, can reduce the side effects of treatment for esophageal cancer. This method delivers radiation in small, timed doses, which may be less harmful to healthy tissue while still effectively targeting cancer cells. The study will compare PLDR radiation combined with chemotherapy to the standard radiation and chemotherapy treatment to see if it reduces esophagitis, a common side effect.

Description

The PULSO trial is investigating a new way to deliver radiation therapy called Pulsed Low-Dose-Rate (PLDR) radiation. This technique involves giving the same total amount of radiation in smaller, timed doses, which may help protect healthy tissue while still effectively treating cancer. The study will test this method in combination with standard chemotherapy for patients with locally advanced esophageal cancer. Researchers hope that PLDR radiation will be less toxic and just as effective as the standard approach. Participants will be randomly assigned to receive either the PLDR radiation or the standard radiation, both combined with chemotherapy, to see which method better reduces the risk of esophagitis, a painful inflammation of the esophagus.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have stage II-IVb esophageal adenocarcinoma, with limited metastases if stage IVb, and considered suitable for full-dose chemoradiation by the doctor.
  • Currently receiving or have received initial chemotherapy and are planned for full-dose chemoradiation, with or without surgery.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have adequate blood cell counts and organ function based on recent tests:
    • Neutrophil count of at least 1,500/mcg
    • Hemoglobin level of at least 8 gm/dL
    • Platelet count of at least 100,000/mcL
    • Kidney function with creatinine clearance of at least 50 ml/min
    • Liver function with total bilirubin within specified limits
  • Women under 65 who can become pregnant must have a negative pregnancy test before joining the study.
  • Agree to use effective birth control during the study if of reproductive potential.
  • Can have other cancers if they do not interfere with the study treatment.
  • Must understand and agree to sign a consent form to participate.

Exclusion Criteria

  • Under 18 years old.
  • Have more than 5 distant cancer metastases.
  • Have recurrent esophageal cancer.
  • Have had non-approved chemotherapy for cancer treatment.
  • Have had previous radiation to the same area that would overlap with the study treatment.
  • Women must not be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Froedtert & the Medical College of Wisconsin53226MilwaukeeWisconsin

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