Testing Arm 2: SABR for metastatic cancer
Official title: Ablative Radiotherapy to Restrain Every Metastasis Safely Treatable (ARREST-2): A Randomized Phase II/III Trial
- 2 groups
- Sites in London and Montreal
- Recruiting
Interventions
- Radiation therapy
Arm 2: SABR
SABR to all tumors 6 Gy x 5 over three weeks
- Radiation therapy
Arm 1: Standard of Care
Standard of care palliative radiotherapy
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
London Health Sciences Centre- London Regional Cancer Program
London, Ontario
- Recruiting
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\> or equal to 11 metastases (the primary tumor does not have to be controlled and can be included as a target if it can feasibly and safely be treated with SABR. If the primary tumor is treated, a minimum of 12 targets are required0 at least 11 metastases are required in addition to the primary tumor.)
- +Brain: MRI is required for all patients with known untreated or previously treated brain metastases. MRI is strongly recommended for all tumor sites with a propensity to develop brian metastases.
- +Liver: For patients with liver metastases, a diagnostic or simulation MRI is required to confirm the total number of metastases.
- +For patients with brain metastases that are going to be treated regardless of the study armArmOne of the groups in a study, each receiving something different.Read more →, there must be additional extracranial disease present that will be treated with SABR on Arm 2 and not treated with SABR on Arm 1.
- +Age 18 or older
- +willing and able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Life expectancy \> or equal to 6 months
- +Histologically confirmed malignancy with evidence of metastatic disease on imaging
- +Investigations required within 12 weeks of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →:
- +Body: 18-FDG PET/CT imaging is recommended, except for tumors where FDG uptake is not expected (e.g. prostate, renal cell carcinoma). PSMA-PET or choline-PET is recommended for prostate cancer. In situations where a PET scan is unavailable, or for tumors that do not take up radiotracer, a CT neck/chest/abdomen/pelvis and bone scan are required.
- +SABR or palliative radiotherapy should commence no later than 2 weeks after randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +ECOG performance status 0-2
- +All sites of disease can be safely treated on a preliminary radiation plan
- +No plans for systemic therapy (i.e. chemotherapy, targeted agent, immunotherapy) for 3 months from the time of enrolment. Reasons may include: a break from systemic therapy is desired by the patient and medical oncologist, the patient declines next line of systemic therapy, or no further systemic therapy options are available. Exceptions include hormone therapy for breast cancer or prostate cancer, which may be continued.
Exclusion
- −Inability to treat all sites of disease. Any brain metastasis \>3 cm in size or a total volume of brain metastases greater than 30 cc.
- −Disseminated disease, including leptomeningeal metastases, peritoneal metastases/carcinomatosis, malignant pleural effusion, and lymphangitis carcinomatosis.
- −For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
- −Solitary or dominant brian metastasis requiring surgical decompression.
- −Radiologic evidence of spinal cord compression.
- −Pregnant or lactating women.
- −Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Chrohn's disease in patients where the GI tract will receive radiotherapy, ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
- −Substantial overlap with a previously treated radiation volume. Prior radiotherapy is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biologically effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with the study PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives ArmArmOne of the groups in a study, each receiving something different.Read more → 1: Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more →.
Registry label: A: Standard of Care
Group B, the comparison group, receives Arm 2: SABR.
Registry label: B: SABR
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 138 people.
The study is currently expected to finish around January 2034.
The main measurement is taken over: Time from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to death from any cause, patients followed for 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Survival — measured over Time from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to death from any cause, patients followed for 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05508464 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Arm 2: SABRRadiation
SABR to all tumors 6 Gy x 5 over three weeks
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Arm 1: Standard of CareRadiation
Standard of care palliative radiotherapy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Time from randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to death from any cause, patients followed for 5 years.
The study as a whole is currently expected to finish around 2034-01-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 138 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: London, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a phase II/III international multicentre randomized trial. Patients will be randomized in a 1:2 ratio between the standard of care (Arm 1) and SABR (Arm 2) to all sites of disease. The study will start as a phase II trial with an opportunity to convert to a phase III trial. The objective of this trial is to determine the impact of SABR on overall survival, progression-free survival, quality of life, and toxicity in patients with polymetastatic disease.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.