Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001119280
Ethics application status
Approved
Date submitted
14/08/2017
Date registered
6/07/2018
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry. Australia
Scientific title
Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry in Australia
Secondary ID [1] 294327 0
Nil known
Universal Trial Number (UTN)
U1111-1200-6879
Trial acronym
RESIN Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer primary or secondary 304384 0
Condition category
Condition code
Cancer 303719 303719 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Patients will have data collected as part of standard of care insertion of Sir-Spheres for treating their primary or secondary liver tumours. Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends. The study will end when there have been 100 patients enrolled or until the coordinating site decides to shut the study.
Intervention code [1] 300840 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303083 0
Safety- measured by functional stablility of the liver during the course of care as per standard of care procedures such as liver function tests and/or CT Scans of liver depending on the Doctor.
Timepoint [1] 303083 0
Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends.
Secondary outcome [1] 337862 0
Tolerability through review of adverse events (abdominal pain and/or pressure
nausea for 1-2 days, temperature, chills, tiredness, loss of appetite) assessed by the Doctor
Timepoint [1] 337862 0
Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends.
Secondary outcome [2] 344380 0
Objective response every 6 months until the study ends or patient completes treatment. These will be liver function tests, CT scans of liver
Timepoint [2] 344380 0
At first treatment then, every 6 months until the study ends, patient completed treatment

Eligibility
Key inclusion criteria
1. Patients who have selected Y90 therapy for the first time to a treat both primary and metastatic diseases of the liver.
2. Provision of written informed consent.
3. Age 18 and older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are being re-treated with Y90, even if new areas are being targeted. If patients have received Y90 treatment as part of their first and ongoing round of Y90 therapy, they are eligible to participate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The registry will assess real world evidence (RWE) around safety, tolerability,
outcomes and document treatment-related information. The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer.

It is hoped that the study findings will lead to a better understanding of SIR-Spheres treatment patterns; provide additional insights into long-term patient outcomes; and guidefuture SIR-Spheres treatment research, especially for those conditions where data are currently limited or lacking. The study originated in the U.S. with Dr Dan Brown, Vanderbilt University Medical Centre as the study chair, it has since been extended to Australia and New Zealand.The potential participating hospitals or centres that will be involved with the registry are estimated to be 15 Australia-wide with the possibility of future international collaborations.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
27/06/2017
Date of last participant enrolment
Anticipated
30/08/2022
Actual
26/02/2019
Date of last data collection
Anticipated
30/08/2023
Actual
4/04/2019
Sample size
Target
100
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 8799 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 8800 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 8801 0
Westmead Rehabilitation Hospital - Merrylands
Recruitment hospital [4] 8802 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 8803 0
Knox Private Hospital - Wantirna
Recruitment hospital [6] 8805 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 16922 0
4066 - Auchenflower
Recruitment postcode(s) [2] 16923 0
3084 - Heidelberg
Recruitment postcode(s) [3] 16924 0
2160 - Merrylands
Recruitment postcode(s) [4] 16925 0
6009 - Nedlands
Recruitment postcode(s) [5] 16926 0
3152 - Wantirna
Recruitment postcode(s) [6] 16928 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297286 0
Commercial sector/Industry
Name [1] 297286 0
Sirtex Technology
Country [1] 297286 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Gibbs
Address
Gibbs Lab SB&PM
WEHI
1G Royal Parade
Parkville 3052
Victoria
Country
Australia
Secondary sponsor category [1] 296255 0
Commercial sector/Industry
Name [1] 296255 0
Sirtex
Address [1] 296255 0
Level 33, 101 Miller Street
North Sydney NSW 2060
Australia
Country [1] 296255 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298396 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 298396 0
Office for Research
The Royal Melbourne Hospital
Level 2 South 300 Grattan Street Parkville 3050
Ethics committee country [1] 298396 0
Australia
Date submitted for ethics approval [1] 298396 0
23/11/2016
Approval date [1] 298396 0
22/12/2016
Ethics approval number [1] 298396 0
2016.372

Summary
Brief summary
The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and Y90 therapy for the first time as treatment for either primary or secondary liver cancer.

Study details
The treatment is for primary and secondary liver cancer. The Radiation-Emitting SIR-Spheres In Non-resectable (RESIN) Liver Tumor involves patients with primary and secondary liver cancer receiving (Y90 resin microspheres) treatment as part of their overall oncologic management. The microsphere are injected into the liver through a blood vessel. This allows a large dose of radiation to be delivered to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.
All visits and procedures related to SIR-Spheres treatment are performed on an outpatient basis per standard of care. Prior to treatment, patients are assessed by physical examination, radiographic evaluation, and blood tests to determine the health of the patient and liver.

Standard of care tests done before this procedure may include:
• physical exam and medical history
• blood tests requiring about 2 tablespoons of blood
• a chest x-ray, CT or MRI scan
• an imaging scan (CT or MRI scan) of the liver

Patients undergo an initial mapping arteriogram, to determine the distribution of blood vessels to the tumor(s), identify possible vessels which are to be avoided due to supply to the stomach/small bowel, and evaluate the amount of shunting through the tumor(s) to the lungs. This procedure is performed under sterile conditions with patients having a small tube (catheter) inserted through the skin. It is usually inserted into the thigh, into a blood vessel going to the liver.

Depending on the size and location of tumors, there may be more than one treatment with SIR-Spheres planned. Repeat treatment is done between 4-8 weeks after the first treatment if there is more disease to treat.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76946 0
Prof Peter Gibbs
Address 76946 0
WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia
Country 76946 0
Australia
Phone 76946 0
+61393452897
Fax 76946 0
+61394982010
Email 76946 0
[email protected]
Contact person for public queries
Name 76947 0
Ms Maria Edmonds
Address 76947 0
WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia
Country 76947 0
Australia
Phone 76947 0
+61393452896
Fax 76947 0
+61394982010
Email 76947 0
[email protected]
Contact person for scientific queries
Name 76948 0
Ms Maria Edmonds
Address 76948 0
WEHI
Gibbs Lab
1 G Royal Parade
Parkville 3052
Victoria
Australia
Country 76948 0
Australia
Phone 76948 0
+61393452896
Fax 76948 0
+61394892010
Email 76948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponser level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.


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
No additional documents have been identified.