Pulsing radiation may spare esophageal cancer patients from agonizing throat pain
NCT ID NCT06906887
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether giving radiation in tiny pulses (pulsed low-dose-rate) instead of the standard continuous dose can lower the risk of severe esophagitis—painful inflammation of the swallowing tube—during chemoradiation for esophageal cancer. About 50 people with stage II to IVb esophageal cancer will be randomly assigned to receive either pulsed or standard radiation alongside chemotherapy. The main goal is to see if fewer patients in the pulsed group need strong painkillers or have trouble eating.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pulsed low-dose-rate radiation
- What this could lead to
- If it works, this radiation technique could make chemoradiation for esophageal cancer much easier to tolerate by reducing severe throat pain.
- What could go wrong
- This is a small, early-phase trial, so the benefit may not hold up in larger studies. The experimental radiation schedule could also be less effective at controlling the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A potential study subject who meets all of the following inclusion criteria is eligible to participate in the study. 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 a. Note: patients with known Gilbert Syndrome can have a total bilirubin \< 2.5 x upper limit of normal (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. Exclusion Criteria: A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study. 1. Age \< 18 years. 2. Extensive distant metastatic cancer, defined as \>5 metastases. 3. 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). 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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