Proton therapy gets a daily Tune-Up in small pilot study
NCT ID NCT06310655
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested whether it's possible to adjust proton radiation plans each day while the patient is on the treatment table. Ten adults with solid tumors took part. The goal was to see if this approach is safe and practical enough to study in a larger trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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May 2024
- Finished
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Nov 2025
- 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: * Oligometastatic or primary malignancy planned for proton SBRT. Disease site should be biopsy-proven primary disease of solid tumor histology with the exception of Hepatocellular carcinoma (HCC). HCC does not need to be biopsy proven if imaging and clinical findings are consistent with the diagnosis. * Must be deemed medically fit for proton SBRT by the treating physician. * Prior radiation therapy is allowed. * At least 18 years of age. * Karnofsky ≥ 70%. * Because radiation therapy is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, or a male suspect he has fathered a child, s/he must inform the treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * Histology of small cell carcinoma. Mixed histologies with a predominantly small cell component are also exclusionary. * 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. * Medical contraindication to proton therapy or any other condition that in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of study entry.
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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.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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