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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
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response
Scientific title
The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response including treatment with imatinib (400 - 800mg/day) followed by nilotinib (800mg/day)
Secondary ID [1] 253272 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumour (GIST) 3440 0
Condition category
Condition code
Cancer 3594 3594 0 0

Study type
Description of intervention(s) / exposure
Patient treatment regimen will be determined by KIT mutational status. For patients recieving less than or equal to 6 weeks of Imatinib will be classified as either exon 9/WT or exon 11. Patients will initially receive 400mg/day of imatinib (also known as Glivec) administered orally in tablet form. Patients will then receive an escalated dose up to 800mg/day imatinib. The timing of dose escalation will depend on the patient KIT mutational status (exon 9/WT or exon 11) and their early response to treatment. For patients who have received more than 6 weeks of imatinib they will continue on at a dose of 400mg/day until RECIST-defined progression where the dose will be escalated up to 800mg/day depending on the patient's response to treatment. The rest of the regime will be the same as patients who have received less than or equal to 6 weeks of imatinib treatment.
Intervention code [1] 3173 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group

Primary outcome [1] 4496 0
Time to ultimate disease progression on study treatment (using Response Evaluation Criteria in Solid Tumors (RECIST criteria)) for the exon 9/WT subgroup of patients
Timepoint [1] 4496 0
Every 3 months while on study treatment. Study treatment will continue until disease progression on nilotinib.
Secondary outcome [1] 7604 0
Time to ultimate disease progression on study treatment (using Response Evaluation Criteria in Solid Tumors (RECIST criteria)) for the exon 11 subgroup of patients
Timepoint [1] 7604 0
Every 3 months while on study treatment. Study treatment will continue until disease progression.
Secondary outcome [2] 7605 0
Safety and tolerability of imatinib and nilotinib. Safety and tolerability will be assessed and monitored by the study nurse or doctor at each patient visit and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCICTCAEv3.0).
Timepoint [2] 7605 0
Every 2 weeks when commencing new treatment regime. Every 3 months when treatment regimen is established. Assessments will continue until the patient leaves the trial or the patient experiences progressive disease.
Secondary outcome [3] 7606 0
Correlation between pharmacokinetic (serum imatinib levels) and pharmacodynamic (Fluorodeoxyglucose Positron Emission Tomography (FDG PET)scan) measures.
Timepoint [3] 7606 0
At 6 weeks and then every 3 months until treatment with imatinib is ceased.

Key inclusion criteria
Patients with metastatic or unresectable GIST. Patients with no prior systemic therapy except 6 weeks or less treatment with imatinib or who have been previously treated with Imatinib but who have had at least 6 months cessation and relapse. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Adequate renal and hepatic function. Patients who have received > 6 weeks of imatinib treatment must be stable for at least 4 weeks at 400mg/day of Imatinib and be evaluable for assessment of objective response according to RECIST criteria.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Current gastroinestinal disease that may affect ability to absorb imatinib.
Pregnant or breastfeeding.
Impaired cardiac function.
Use of warfarin.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 10452 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 10453 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 10454 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [4] 10455 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 10456 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 10457 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 10458 0
Border Medical Oncology - Albury
Recruitment hospital [8] 10459 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 10460 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 10461 0
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [11] 10462 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 10463 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 22161 0
2031 - Randwick
Recruitment postcode(s) [2] 22162 0
2298 - Waratah
Recruitment postcode(s) [3] 22163 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 22172 0
2605 - Garran
Recruitment postcode(s) [5] 22167 0
2640 - Albury
Recruitment postcode(s) [6] 22165 0
3000 - Melbourne
Recruitment postcode(s) [7] 22164 0
3050 - Parkville
Recruitment postcode(s) [8] 22166 0
3128 - Box Hill
Recruitment postcode(s) [9] 22169 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 22170 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 22168 0
5042 - Bedford Park
Recruitment postcode(s) [12] 22171 0
7000 - Hobart
Recruitment outside Australia
Country [1] 1050 0
New Zealand
State/province [1] 1050 0
Auckland, Wellington, Canterbury, Manawatu
Country [2] 10236 0
State/province [2] 10236 0

Funding & Sponsors
Funding source category [1] 3623 0
Other Collaborative groups
Name [1] 3623 0
Australiasian Gastrointestinal Trials Group (AGITG)
Address [1] 3623 0
Locked Bag 77,
Camperdown 1450
Country [1] 3623 0
Primary sponsor type
Other Collaborative groups
Locked Bag 77,
Camperdown 1450
Secondary sponsor category [1] 3258 0
Name [1] 3258 0
Address [1] 3258 0
Country [1] 3258 0

Ethics approval
Ethics application status
Ethics committee name [1] 5675 0
SSWSAHS Ethics Committee (RPAH zone)
Ethics committee address [1] 5675 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
Ethics committee country [1] 5675 0
Date submitted for ethics approval [1] 5675 0
Approval date [1] 5675 0
Ethics approval number [1] 5675 0

Brief summary
The REGISTER study aims to maximise the treatment potential of Glivec (Registered trade mark) (also known as imatinib) in patients with metastatic or unresectable Gastro-intestinal Stromal Tumour (GIST) by individualising treatment. Treatment for each patient will be determined according to the biological features of their tumour when examined in the laboratory. We know that tumours with certain findings are less likely to do well on standard treatment. Patients with these types of tumours will be treated with an increased dose of Glivec (Registered trade mark). Patients with tumours that we know are more likely to do well will be treated with a standard dose of Glivec (Registered trade mark) but will move on to an increased dose when the standard dose stops being effective. The response to treatment will be measured using Computerized axial Tomography (CT) scans. Early response will be measured using Fluorodeoxyglucose Positron Emission Tomography (FDG PET) scans.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28770 0
Dr Jayesh Desai
Address 28770 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 3050
Country 28770 0
Phone 28770 0
+61 3 9656 1111
Fax 28770 0
Email 28770 0
Contact person for public queries
Name 11927 0
Ms REGISTER Trial Coordinator
Address 11927 0
Locked Bag 77
Camperdown NSW 1450
Country 11927 0
Phone 11927 0
+61 2 9562 5000
Fax 11927 0
+61 2 9562 5094
Email 11927 0
Contact person for scientific queries
Name 2855 0
Ms REGISTER Trial Coordinator
Address 2855 0
Locked Bag 77
Camperdown NSW 1450
Country 2855 0
Phone 2855 0
+61 2 9562 5000
Fax 2855 0
+61 2 9562 5094
Email 2855 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary