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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05270707




Registration number
NCT05270707
Ethics application status
Date submitted
14/02/2022
Date registered
8/03/2022

Titles & IDs
Public title
HyperArc Registry Study
Scientific title
HyperArc Registry Study
Secondary ID [1] 0 0
VAR-2019-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Metastases 0 0
CNS Neoplasm 0 0
CNS Disorder, Intracranial 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Stereotactic radiosurgery

Treatment: Other: Stereotactic radiosurgery
HyperArc is a radiotherapy treatment with a structured workflow to plan and deliver stereotactic radiosurgery (SRS).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
follow until death, on average approximately 2 years
Secondary outcome [1] 0 0
Local tumor control
Timepoint [1] 0 0
follow until death, on average approximately 2 years
Secondary outcome [2] 0 0
HyperArc Patterns of Care
Timepoint [2] 0 0
Limited to course of treatment: up to 4 weeks

Eligibility
Key inclusion criteria
* Received or scheduled to receive treatment using the HyperArc treatment method
* Age of legal adult according to local law
* Signed informed consent form, or, informed consent waived by the local ethics board/institutional review board
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None, apart from not meeting Inclusion Criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2031
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 0 0
Icon Cancer Centre Canberra - Bruce
Recruitment hospital [2] 0 0
Icon Cancer Centre Greenslopes - Greenslopes
Recruitment hospital [3] 0 0
Icon Cancer Centre Maroochydore - Maroochydore
Recruitment hospital [4] 0 0
Icon Cancer Centre Gold Coast Private - Southport
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Varian, a Siemens Healthineers Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lawrence MacDonald, PhD
Address 0 0
Country 0 0
Phone 0 0
2066129290
Fax 0 0
Email 0 0
HyperArcRegistry@varian.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05270707