Status:
RECRUITING
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Esophageal Cancer
Oesophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
PLDR radiation technique has been shown to kill cancer cells while limiting normal tissue toxicity. In PLDR, subjects receive the same total dose of radiation for each treatment, but the treatment is ...
Eligibility Criteria
Inclusion
- A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.
- Age ≥ 18 years.
- Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).
- Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+/- esophagectomy).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate hematologic function within 30 days prior to registration defined as follows:
- Absolute Neutrophil Count ≥ 1,500/mcg
- Hemoglobin ≥ 8 gm/dL
- Platelets ≥ 100,000/mcL.
- 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.
- Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN
- a. Note: patients with known Gilbert Syndrome can have a total bilirubin \< 2.5 x upper limit of normal (ULN).
- 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.
- 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.
- 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.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Age \< 18 years.
- Extensive distant metastatic cancer, defined as \>5 metastases.
- Recurrent esophageal cancer.
- a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).
- Prior non-approved chemotherapy for the treatment of cancer.
- Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.
- Women must not be pregnant or breast-feeding.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2032
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06906887
Start Date
June 17 2025
End Date
June 1 2032
Last Update
June 29 2025
Active Locations (1)
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1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226