Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05270707




Registration number
NCT05270707
Ethics application status
Date submitted
14/02/2022
Date registered
8/03/2022
Date last updated
14/02/2023

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
The HyperArc registry is designed to collect data from which the efficacy of the HyperArc
procedure can be assessed and compared to alternative treatments.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05270707
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05270707