One shot or several? new trial tests shorter radiation for cancer spread
NCT ID NCT05784428
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a single, high-dose radiation session works as well as multiple sessions for people whose cancer has spread to a few places (oligometastatic disease). About 600 participants will be randomly assigned to receive either one or several radiation treatments. The goal is to see if the single dose causes fewer side effects and maintains quality of life while still controlling the cancer.
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 (stereotactic ablative radiotherapy)
- What this could lead to
- If it works, this could show that a single, shorter radiation session is just as effective as multiple sessions for controlling limited cancer spread, with fewer side effects and lower costs.
- What could go wrong
- This is a non-inferiority trial, meaning it aims to prove that one session is not worse than multiple. It is still recruiting, and results may show that single sessions are less effective or cause unexpected side effects in some patients.
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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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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About 598 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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May 2035
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: * 1-5 current oligometastatic or oligo-progressive lesions * Age 18 years or older * Able to provide informed consent * Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver/family/friend/research staff using electronic methods after providing consent to email use. * Life expectancy \> 6 months * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging \[e.g. primary unknown\]) * A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment * Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment * Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography \[PET-CT\]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment * Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment. * For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment. * If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment * If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment * Patient is judged able to: * Maintain a stable position during therapy * Tolerate immobilization device(s) that may be required to deliver SABR safely * Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date Exclusion Criteria: * Uncontrolled concurrent malignant cancer * Lesion in femoral bone requiring surgical fixation * No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion. * Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma. * Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs). * Current malignant pleural effusion * Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm. * Inability to treat all sites of oligometastatic or oligoprogressive disease * Presence of brain metastases as the sole site of disease * Maximum size of 5 cm for lesions outside the brain, except: * Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis) * Any brain metastasis \> 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded * Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed * Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \>12 * Dominant brain metastasis requiring surgical decompression * Surgical resection of all metastases (i.e. no lesion available to be treated with SABR) * Complete response to systemic therapy, defined as the absence of visible disease on imaging * 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
14 sites in 2 countries. 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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BC Cancer
RECRUITINGKelowna, British Columbia, Canada
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BC Cancer
RECRUITINGPrince George, British Columbia, V2M 7E9, Canada
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BC Cancer
RECRUITINGSurrey, British Columbia, Canada
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BC Cancer
RECRUITINGVancouver, British Columbia, Canada
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BC Cancer - Victoria
NOT_YET_RECRUITINGVictoria, British Columbia, Canada
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Beacon Hospital
RECRUITINGDublin, Leinster, D18 AK68, Ireland
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Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
RECRUITINGCork, Munster, T12 DV56, Ireland
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Cork University Hospital
RECRUITINGCork, Munster, T12 DC4A, Ireland
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Health Sciences North Research Institute
RECRUITINGGreater Sudbury, Ontario, P3E 5J1, Canada
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Mater Private Hospital
RECRUITINGDublin, Leinster, D07 WKW8, Ireland
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Princess Margaret Cancer Centre | University Health Network
RECRUITINGToronto, Ontario, M5G 1X6, Canada
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St. Luke's Radiation Oncology Network
RECRUITINGDublin, Dublin, D06 E1C9, Ireland
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UPMC Whitfield Hospital - Waterford
RECRUITINGWaterford, Munster, X91 DH9W, Ireland
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University Hospital Galway
RECRUITINGGalway, Connacht, H91 YR71, Ireland
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