Testing Targeting All Brain Metastases for adult brain metastases
Official title: RAPid SimPLE Targeted Radiation Treatment for Brain Metastases
Randomized Phase II Non-Inferiority Study of 5-Day Versus 1-Day RAPid SimPLE (RAPPLE) Targeted Radiation Treatment for Brain Metastases
- Phase 2
- 2 groups
- Sites in Abbotsford British Columbia, Kelowna and 4 more cities
- Recruiting
Interventions
- Radiation therapy
Targeting All Brain Metastases
Volumetric Modulated Arc Therapy
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
BC Cancer - Abbotsford
Abbotsford British Columbia, British Columbia
- Recruiting
BC Cancer - Kelowna
Kelowna, British Columbia
- Recruiting
BC Cancer - Prince George
Prince George, British Columbia
- Recruiting
BC Cancer - Surrey
Surrey, British Columbia
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia
- Recruiting
BC Cancer - Victoria
Victoria, British Columbia
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Brain metastases of any size
- +Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted
- +Subjects must meet all of the following criteria to be eligible for participation in this study:
- +Pathological diagnosis of a non-hematopoietic malignancy
- +Presence of extracranial disease
- +Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https://brainmetgpa.com/) or Graded Prognostic Assessment ≤ 2.0 (Appendix I)
- +Able to complete the EuroQOL (EQ-5D-5L) questionnaire
- +Willing and able to have regular imaging follow upFollow-upContinued check-ins after the treatment part is finished.Read more →
- +Feasible to start protocolProtocolThe detailed plan a study must follow.Read more → treatment within 14 days of participant enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Karnofsky Performance Score (KPS) ≥ 50
Exclusion
- −Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)
- −Subjects are excluded from the study if any of the following criteria apply:
- −Inability to have a brain MRI
- −WBRT less than 3 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Multiple sclerosis
- −Neurologically declining despite corticosteroids
- −Germ cell and primary brain tumours
- −Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
- −Any other serious intercurrent illness or medical condition judged by the local investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to compromise the participant's safety, preclude safe administration of the planned protocolProtocolThe detailed plan a study must follow.Read more → treatment, or prevent the participant from being managed according to the protocol guidelines
- −Potentially fertile men or women of childbearing potential who are unwilling to employ highly effective contraception
- −Appropriate for surgery or stereotactic radiosurgery
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.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
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 Targeting All Brain Metastases.
Registry label: A: 20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases
Group B receives Targeting All Brain Metastases.
Registry label: B: 8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases
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 an age range of 18 years to 100 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Survival Time — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05050929 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 Targeting All Brain MetastasesRadiation
Volumetric Modulated Arc Therapy
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: an age range of 18 years to 100 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.maximumAge
- 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 an age range of 18 years to 100 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2027-12-30.
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 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Abbotsford British Columbia, British Columbia, Canada; Kelowna, British Columbia, Canada; Prince George, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, 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
The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy / 1 is non-inferior to 20 Gy / 5 in terms of overall survival for patients with poor prognosis.
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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.