RECRUITING

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

Conditions

Esophageal Cancer Oesophageal Cancer GastroEsophageal Cancer Pulsed Low-Dose-Rate Radiation Chemoradiation esophagitis Esophagectomy Pulsed reduced dose rate radiation Pulsed radiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2025-06-17

Study Completion:2032-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06906887

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Lindsay Puckett, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Lindsay Puckett, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-17

Study Completion Date2032-06-01

Study Record Updates

Study Start Date2025-06-17

Study Completion Date2032-06-01

Terms related to this study

Keywords Provided by Researchers

Pulsed Low-Dose-Rate Radiation
Chemoradiation
esophagitis
Esophagectomy
Esophageal Cancer
Oesophageal Cancer
GastroEsophageal Cancer
Pulsed reduced dose rate radiation
Pulsed radiation

Additional Relevant MeSH Terms

Esophageal Cancer
Oesophageal Cancer
GastroEsophageal Cancer