Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000712606
Ethics application status
Approved
Date submitted
3/11/2005
Date registered
4/11/2005
Date last updated
18/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Adjuvant GIST Trial
Scientific title
Intermediate and high risk localised, completely resected, gastrointestinal stromal tumours (GIST) expressing KIT recepto: a controlled randomised trial on adjuvant Imatinib mesylate (Glivec) versus no further therapy after complete surgery
Secondary ID [1] 217 0
National Clinical Trials Registry: NCTR553
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal stromal tumours (GIST) 862 0
Condition category
Condition code
Cancer 929 929 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Imatinib mesylate (400mg/day) for two years
Intervention code [1] 749 0
Treatment: Drugs
Comparator / control treatment
No further anti-tumour therapy
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1217 0
Time to Imatinib Failure. This information will be collected from medical records.
Timepoint [1] 1217 0
Until Progression of disease. This information will be collected from medical records.
Secondary outcome [1] 2213 0
Relapse-free survival. This information will be collected from medical records.
Timepoint [1] 2213 0
Until relapse of patient. This information will be collected from medical records.
Secondary outcome [2] 263571 0
Relapse-free interval. This information will be collected from medical records.
Timepoint [2] 263571 0
Until first patient relapse. This information will be collected from medical records.
Secondary outcome [3] 263572 0
Adverse events. This information will be collected from medical records.
Timepoint [3] 263572 0
Until occurance of an adverse event. This information will be collected from medical records.
Secondary outcome [4] 263573 0
Overall Survival. This information will be collected from medical records.
Timepoint [4] 263573 0
Until patient death. This information will be collected from medical records.

Eligibility
Key inclusion criteria
Histologically proven diagnosis of GIST (positive for CD117), intermediate or high risk of relapse documented on surgical specimen, surgery performed between 2 weeks and 3 months before treatment start , non evidence of residual macroscopic disease after surgery (R0 or R1 resection only), no prior treatment for GIST (ie. radiotherapy, chemotherapy, molecular targeted therapy, biological therapy), absence of distant metastases, WHO performance status 0-2.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using the EORTC Online Randomised Trial Access (ORTA) system. A minimisation technique will be used for random treatment allocation stratifying for center, risk category (high vs. intermediate), tumour site (gastric vs. other) and resection level (R0 vs. R1)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2005
Actual
20/10/2008
Date of last participant enrolment
Anticipated
Actual
31/10/2008
Date of last data collection
Anticipated
Actual
13/07/2017
Sample size
Target
400
Accrual to date
Final
908
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 1025 0
Charities/Societies/Foundations
Name [1] 1025 0
multi-state Cancer Council grant
Country [1] 1025 0
Australia
Funding source category [2] 1026 0
Commercial sector/Industry
Name [2] 1026 0
industry
Country [2] 1026 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AGITG
Address
6-10 Mallett Street Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 890 0
Commercial sector/Industry
Name [1] 890 0
Novartis Pharmaceuticals Pty Limited
Address [1] 890 0
54 Waterloo Road
North Ryde NSW 2113
Country [1] 890 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36280 0
Dr Dusan Kotasek
Address 36280 0
Ashford Cancer Centre
48 Marleston Ave
Ashford 5035
SA Australia
Country 36280 0
Australia
Phone 36280 0
+61 08 83510211
Fax 36280 0
Email 36280 0
[email protected]
Contact person for public queries
Name 9938 0
Adjuvant GIST Trial Coordinator
Address 9938 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9938 0
Australia
Phone 9938 0
+61 2 95625000
Fax 9938 0
+61 2 95625094
Email 9938 0
[email protected]
Contact person for scientific queries
Name 866 0
Dr Dusan Kotasek
Address 866 0
Ashford Cancer Centre Research
Level 1, Tennyson Centre
520 South Road
Kurralta Park
South Australia 5037
Country 866 0
Australia
Phone 866 0
+61 8 8292 2240
Fax 866 0
+61 8 8292 2241
Email 866 0
[email protected]

No information has been provided regarding IPD availability


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.