RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Esophageal Cancer
Intervention / Treatment

-

Contacts and Locations

Milwaukee

Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 18 years.
  • 2. Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).
  • 3. Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+/- esophagectomy).
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • 5. Adequate hematologic function within 30 days prior to registration defined as follows:
  • 1. Absolute Neutrophil Count ≥ 1,500/mcg
  • 2. Hemoglobin ≥ 8 gm/dL
  • 3. Platelets ≥ 100,000/mcL.
  • 6. Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml/min as calculated by the Cockcroft-Gault equation.
  • 7. Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN
  • 8. Female patients \<65 years of age and of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.
  • 9. Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.
  • 10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • 11. Ability to understand a written informed consent document, and the willingness to sign it.
  • 1. Age \< 18 years.
  • 2. Extensive distant metastatic cancer, defined as \>5 metastases.
  • 3. Recurrent esophageal cancer.
  • 4. Prior non-approved chemotherapy for the treatment of cancer.
  • 5. Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.
  • 6. Women must not be pregnant or breast-feeding.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Lindsay Puckett, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2032-06-01