One shot or several? new trial tests shorter radiation for cancer spread

NCT ID NCT05784428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 598 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

May 2035

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • BC Cancer

    RECRUITING

    Kelowna, British Columbia, Canada

  • BC Cancer

    RECRUITING

    Prince George, British Columbia, V2M 7E9, Canada

  • BC Cancer

    RECRUITING

    Surrey, British Columbia, Canada

  • BC Cancer

    RECRUITING

    Vancouver, British Columbia, Canada

  • BC Cancer - Victoria

    NOT_YET_RECRUITING

    Victoria, British Columbia, Canada

  • Beacon Hospital

    RECRUITING

    Dublin, Leinster, D18 AK68, Ireland

  • Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre

    RECRUITING

    Cork, Munster, T12 DV56, Ireland

  • Cork University Hospital

    RECRUITING

    Cork, Munster, T12 DC4A, Ireland

  • Health Sciences North Research Institute

    RECRUITING

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Mater Private Hospital

    RECRUITING

    Dublin, Leinster, D07 WKW8, Ireland

  • Princess Margaret Cancer Centre | University Health Network

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • St. Luke's Radiation Oncology Network

    RECRUITING

    Dublin, Dublin, D06 E1C9, Ireland

  • UPMC Whitfield Hospital - Waterford

    RECRUITING

    Waterford, Munster, X91 DH9W, Ireland

  • University Hospital Galway

    RECRUITING

    Galway, Connacht, H91 YR71, Ireland

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