Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000385842
Ethics application status
Approved
Date submitted
3/02/2021
Date registered
7/04/2021
Date last updated
11/11/2021
Date data sharing statement initially provided
7/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Long-Term, Prospective and Retrospective, Observational Registry To Assess Technical Data and Clinical Outcomes For Patients of Multiple Cancer Types Following Treatment with Radiation Therapy Using MR-Linac
Scientific title
A Long-Term, Prospective and Retrospective, Observational Registry Assessing Technical Data and Clinical Outcomes Following Treatment with MR-Linac
Secondary ID [1] 303306 0
Nil
Universal Trial Number (UTN)
U1111-1264-6122
Trial acronym
ADAPT-MRL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 320546 0
Condition category
Condition code
Cancer 318402 318402 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Radiation therapy delivered using an MR-Linac by radiation oncologists and their associated team (physicist, radiation therapist etc.).

Treatment is delivered to patients individually in a clinic. The dose of radiation, the number of times and frequency of its delivery is prescribed for each individual patient based on their disease and health status. This prescription is determined by the radiation oncologist and treatment plans are verified by their colleagues. Patients are involved in completing patient reported outcomes measures and may choose to allow optional images to be taken.

Data will be collected from the electronic medical record used at participating sites.

Retrospective data will be collected for participants who enrolled in the study prior to relevant patient reported outcomes measures being available. The information collected and timepoints for these patients is identical to prospective patients except patient reported outcomes will not be available.

This study will capture data on the treatments delivered using the MR-Linac machine.
Intervention code [1] 319622 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326383 0
Survival as assessed by medical record review.
Timepoint [1] 326383 0
Month 24 (from that last fraction of radiation administered).
Primary outcome [2] 326384 0
Composite outcome: Disease progress as assessed by tumour response (clinical and pathological), disease-free survival and progression-free survival

Data will be collected from the patient's medical record.
Timepoint [2] 326384 0
Month 24 (from that last fraction of radiation administered).
Primary outcome [3] 326388 0
Toxicities assessed by physical exam and patient reported symptoms
Timepoint [3] 326388 0
Month 24
Secondary outcome [1] 391278 0
Composite Outcome: Assess MR-Linac technical data from MRIs/CTs ie. Dose volume histograms, deformation vector fields, 2-dimensional motion data, and machine and treatment log files.
Timepoint [1] 391278 0
End of treatment
Secondary outcome [2] 392467 0
Level of function using ECOG performance status
Timepoint [2] 392467 0
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months following the last treatment session.
Secondary outcome [3] 393728 0
Health-related quality of life using EQ-5D-5L
Timepoint [3] 393728 0
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months following the last treatment session.
Secondary outcome [4] 393729 0
Quality of life using EORTC-QLQ-C30
Timepoint [4] 393729 0
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months following the last treatment session.
Secondary outcome [5] 393730 0
Disease-specific health-related quality of life of prostate cancer patients using EORTC QLQ-PR25
Timepoint [5] 393730 0
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months following the last treatment session.
Secondary outcome [6] 393731 0
Disease-specific health-related quality of life of pancreatic cancer patients using QLQ-PAN26
Timepoint [6] 393731 0
Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months following the last treatment session.

Eligibility
Key inclusion criteria
1. Willing to provide written informed consent;
2. Participant must be 18 years or older, at the time of signing the informed consent;
3. Scheduled for treatment on an MR-Linac device or have completed treatment on an MR-Linac device.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The sample size considerations for this Registry are not based on a power calculation. It is believed that the proposed sample size will allow a reliable assessment to be made based on the statistics that will be generated to support the Registry aims and endpoints.

The statistical analysis plan will be finalised prior to database lock and will include a technical and detailed description of the statistical analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
2/09/2030
Actual
Date of last data collection
Anticipated
1/09/2032
Actual
Sample size
Target
10000
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18555 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 32925 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 23422 0
United States of America
State/province [1] 23422 0
Country [2] 23423 0
United Kingdom
State/province [2] 23423 0

Funding & Sponsors
Funding source category [1] 307719 0
Commercial sector/Industry
Name [1] 307719 0
Elekta Limited
Country [1] 307719 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare Clinical CRO Pty Ltd
Address
Buildings 1&11, The Mill, 41-43 Bourke Road, Alexandria, NSW, 2015
Country
Australia
Secondary sponsor category [1] 308445 0
None
Name [1] 308445 0
Address [1] 308445 0
Country [1] 308445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307747 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 307747 0
St Vincent’s Hospital Sydney Research Office, St Vincent’s Health Network, Translational Research Centre, 97-105 Boundary Street, Darlinghurst, NSW 2010
Ethics committee country [1] 307747 0
Australia
Date submitted for ethics approval [1] 307747 0
05/06/2020
Approval date [1] 307747 0
17/07/2020
Ethics approval number [1] 307747 0
2020/ETH01414

Summary
Brief summary
ADAPT-MRL is a multi-site, multinational, observational cohort registry designed to collect data on the use of the MR-Linac machine for radiation therapy oncology and patient outcomes. The registry will provide a linked repository of technical and clinical data that will be shared with the device manufacturer.

Who is it for?
You may be eligible to be involved in this registry if you have cancer and are scheduled for treatment using an MR-Linac machine for radiation therapy.

Study details
Participants will be enrolled in the study, attend standard of care treatment and follow up visits at 3, 6, 9, 12, 18 and 24 months. Participants are asked to complete additional quality of life surveys at these visits and may choose to have additional scans performed.

It is expected the registry will recruit patients for up to 10 years.

This data will be used to leverage the MR-Linac’s capabilities and design new and improved treatment strategies. An estimated 10,000 patients will be enrolled to this registry across 10 or more study sites situated in Australia and internationally (additional sites to be added).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108358 0
Dr Jeremy de Leon
Address 108358 0
Centre for radiation oncology St Vincent's Hospital, Level A/438 Victoria St, Darlinghurst NSW 2010
Country 108358 0
Australia
Phone 108358 0
+61 2 8302 5400
Fax 108358 0
Email 108358 0
[email protected]
Contact person for public queries
Name 108359 0
Mr Michael Plit
Address 108359 0
Building 1&11, The Mill, 41-43 Bourke Rd, Alexandria NSW 2015
Country 108359 0
Australia
Phone 108359 0
+61 2 8236 3300
Fax 108359 0
Email 108359 0
[email protected]
Contact person for scientific queries
Name 108360 0
Dr Jeremy de Leon
Address 108360 0
Centre for radiation oncology St Vincent's Hospital, Level A/438 Victoria St, Darlinghurst NSW 2010
Country 108360 0
Australia
Phone 108360 0
+61 2 8302 5400
Fax 108360 0
Email 108360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data and technical data collected from the MR-Linac machine
When will data be available (start and end dates)?
Start: 31-Mar-2021, no end date determine.
Available to whom?
Elekta, participants in the Momentum registry who provide a methodologically sound proposal, and on case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Evaluate long-term outcomes and to aid further technical development of MR-linac-based MR-guided Radiation Therapy
How or where can data be obtained?
Access subject to approvals by GenesisCare and Principal Investigator [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIMR-Linac guided adaptive stereotactic ablative body radiotherapy for recurrent cardiac sarcoma with mitral valve bioprosthesis – a case report2023https://doi.org/10.1002/jmrs.669
N.B. These documents automatically identified may not have been verified by the study sponsor.