NCT06906887 · Medical College of Wisconsin
PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
What this study is about
This is a forward-looking, randomly assigned, where both patients and doctors know the treatment given, two-treatment group$1 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.
View original scientific 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.
Interventions
DRUG
Induction 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.
DRUG
Chemotherapy
The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.
RADIATION
Conventional 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.
RADIATION
Pulsed 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.
PROCEDURE
Surgery
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.
Primary outcome measures
New prescription for narcotics
Time frame: Up to 6 weeks after radiation treatment
The number of subjects requiring a new prescription for narcotics.
Increasing existing narcotics
Time frame: Up to 6 weeks after radiation treatment
The number of subjects increasing existing narcotics by 25%.
Oral intake
Time frame: Up to 6 weeks after radiation therapy
The number of subjects transitioning from solid to liquid or liquid to no oral intake.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2025 · Source of record for eligibility and locations