High-Dose radiation may extend life for patients with a few cancer spots

NCT ID NCT03862911

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tests whether a precise, high-dose radiation treatment called SABR, when added to standard care, helps people with 1 to 3 metastatic tumors live longer and have a better quality of life. About 330 adults with controlled primary tumors and up to 8 past metastases are participating. The approach is non-invasive and done in outpatient visits, aiming to control cancer spread without lifelong medication.

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 330 people

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

Started

Nov 2019

Expected to finish

Dec 2030

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: * Total number of 1-3 current metastases, and a maximum 8 lifetime metastases * Age 18 or older * Willing to provide informed consent * ECOG score 0-2 * Life expectancy \>6 months * Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. * Controlled primary tumor * defined as: at least 3 months since original tumor treated definitively, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging) * A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment * Not suitable for resection at all sites or decline surgery * Patient has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR). CT neck as clinically indicated. * Patient has had a nuclear bone scan (if no PET-CT) within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR) * If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG PET scan or CT (chest, abdomen, pelvis) and bone scan within 8 weeks prior to enrollment, and with 12 weeks prior to treatment (if randomized to SABR). CT neck as clinically indicated. * If colorectal primary with rising CEA, but equivocal imaging, patient has had an FDG PET scan within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR) * Patient has had CT or MRI brain imaging if primary has a propensity for CNS metastasis within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR) * 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 Women of Child-Bearing potential (WOCBP) within 4 weeks of RT start date * Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, via paper or online using REDCap (if email address is provided by participant on the informed consent) Waivers to the inclusion criteria will NOT be allowed. Exclusion Criteria: * Lesion in femoral bone requiring surgical fixation * Chemotherapy agents (cytotoxic, or molecularly targeted agents) used within the period of time commencing 2 weeks prior to radiation, lasting until 1 week after the last fraction for patients randomized to SABR * Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the 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 conventional radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with one of the study PIs. * Concurrent malignant cancer, or history of malignant cancers within the past 5 years * Malignant pleural effusion * History of poor lung function (if treating near lung) * History of poor liver function (if treating near liver) * Inability to treat all sites 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 cm in size or a total volume of brain metastases greater than 30 cc. * Clinical or radiologic evidence of spinal cord compression, or epidural tumor within \<2 mm of the spinal cord. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 8 lifetime metastases. * Dominant brain metastasis requiring surgical decompression * Pregnant or breastfeeding women Waivers to exclusion criteria will NOT be allowed.

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Conditions

The condition(s) this trial relates to.

metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, United Kingdom

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • BC Cancer

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BC Cancer

    Surrey, British Columbia, Canada

  • BC Cancer

    Vancouver, British Columbia, Canada

  • BC Cancer

    Victoria, British Columbia, Canada

  • BC Cancer - Prince George

    Prince George, British Columbia, V2M 7E9, Canada

  • Beacon Hospital

    Dublin, Sandyford, D18 AK68, Ireland

  • Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdom

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

    Cork, Ireland

  • Cancer Care Griffith

    Griffith, New South Wales, Australia

  • Edinburgh Cancer Centre

    Edinburgh, Scotland, United Kingdom

  • London Health Sciences Centre

    London, Ontario, Canada

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650, Australia

  • St. Luke's Radiation Oncology Network

    Rathgar, Dublin, 6, Ireland

  • Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Walker Family Cancer Centre

    Saint Catharines, Ontario, L2S 0A9, Canada

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