One-Shot radiation may ease cancer pain as well as multiple sessions
NCT ID NCT04068649
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a single, precise dose of radiation (SBRT) can relieve pain and improve quality of life in people with cancer that has spread, compared to the usual multiple sessions of standard radiation. About 1,500 participants with metastatic tumors causing symptoms will be randomly assigned to one of the two approaches. The goal is to see if the faster treatment works just as well with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (SBRT or standard palliative radiation)
- What this could lead to
- If successful, this could show that a single, precise dose of radiation works as well or better than multiple standard doses for relieving pain and improving quality of life in people with metastatic cancer.
- What could go wrong
- This is a phase 2 trial, so results are still preliminary. The single-dose approach may not control pain as effectively for all patients, and there could be unknown side effects from the higher dose per session.
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 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Nov 2027
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: * Pathologically confirmed malignancy * Clinical or pathologic evidence of metastatic disease * A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted * Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease) * Participants with known brain metastases * Pregnant or nursing female participants * Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage * Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site * Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; * Transmural myocardial infarction within the last 3 months; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Unwilling or unable to follow protocol requirements * Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
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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
3 sites. 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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Good Samaritan Hospital
RECRUITINGWest Islip, New York, 11795, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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The Cancer Institute at St. Francis Hospital
RECRUITINGEast Hills, New York, 11548, United States
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