Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000681257
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
10/08/2009
Date last updated
23/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
Scientific title
A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to imatinib mesylate
Universal Trial Number (UTN)
Trial acronym
SURGIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-intestinal stromal tumour (GIST) 237049 0
Condition category
Condition code
Cancer 237369 237369 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery to remove residual disease and continued treatment with imatinib mesylate.
Patients allocated to the intervention arm will have surgery within 4 weeks of randomisation. The preferred surgery will be a midline laparotomy, but all abdominal incisions will be allowed.
All patients will be taking imatinib according to standard clinical practice for the duration of the trial.
Intervention code [1] 236771 0
Treatment: Surgery
Comparator / control treatment
Patient on imatinib mesylate according to standard clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 238173 0
Progression free survival, defined according to the RECIST criteria for tumour response.
Timepoint [1] 238173 0
For patients randomised to receive surgery:
One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.
For patient randomised to the control arm (no surgery):
Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.
Secondary outcome [1] 242466 0
Overall survival
Timepoint [1] 242466 0
For patients randomised to receive surgery:
One month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. After progression survival will be assessed every 6 months until death.
For patient randomised to the control arm (no surgery):
Two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression. After progression survival will be assessed every 6 months until death.
Secondary outcome [2] 242468 0
Pathological response to imatinib (patients in surgery arm only), based on the histology of resected specimens.
Timepoint [2] 242468 0
Once only at the time of surgery
Secondary outcome [3] 242469 0
Quality of life
Timepoint [3] 242469 0
For patients randomised to receive surgery:
Before randomization, one month after surgery, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.
For patient randomised to the control arm (no surgery):
Before randomization, two months after randomisation, five months after randomization then every 3 months for the first 5 year after randomization and then every 6 months, until disease progression.

Eligibility
Key inclusion criteria
- Histologically confirmed gastro-intestinal stromal tumour (GIST).
- Metastatic disease (liver and/or abdominal cavity)
- Treatment with imatinib mesylate for 6 - 12 months either as standard care or within other clinical studies.
- Progression not experienced on imatinib.
- Surgically resectable disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous treatment with imatinib or other tyrosince kinase inhibitor (TKI) other than treatment with imatinib in the past 6 - 12 months.
- Extra-abdominal matastases
- Myocardial infarction, unstable or uncontrolled cardiac disease within 6 months prior to study entry
- Coumarin-type anticoagulant >2mg/day within 7 days prior to study entry
- Pregnancy/breastfeeding

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)
After the patient has consented to participate in the study they will be screened to ensure that they meet the eligibility requirements of the study.
When the patient is enrolled, the treatment allocation will be randomly selected using an internet-based randomisation system. The treatment allocation is not blinded. The patient and their clinician will be informed of the patient's treatment allocation at the time of enrolment in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation is determined using minimisation. Stratification factors are institution, site of tumour origin and site of metastases.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA
Recruitment postcode(s) [1] 1800 0
2031
Recruitment postcode(s) [2] 1801 0
3050
Recruitment postcode(s) [3] 1802 0
4102
Recruitment postcode(s) [4] 1803 0
5042
Recruitment postcode(s) [5] 2003 0
2031
Recruitment outside Australia
Country [1] 1835 0
New Zealand
State/province [1] 1835 0
Christchurch
Country [2] 1836 0
New Zealand
State/province [2] 1836 0
Auckland
Country [3] 1837 0
Belgium
State/province [3] 1837 0
Not known
Country [4] 1838 0
France
State/province [4] 1838 0
Not known
Country [5] 1839 0
Italy
State/province [5] 1839 0
Not known
Country [6] 1840 0
Belgium
State/province [6] 1840 0

Funding & Sponsors
Funding source category [1] 237170 0
Other Collaborative groups
Name [1] 237170 0
European Organisation for Research and Treatment of Cancer (EORTC)
Country [1] 237170 0
Belgium
Primary sponsor type
Other Collaborative groups
Name
European Organisation for Research and Treatment of Cancer (EORTC)
Address
Avenue Mounierlaan, 83/11
Brussel 1200 Bruxelles
Country
Belgium
Secondary sponsor category [1] 4659 0
Other Collaborative groups
Name [1] 4659 0
Australasian Gastro-Intestinal Trials Group (AGITG)
Address [1] 4659 0
Locked Bag 77
Camperdown
NSW 1450
Country [1] 4659 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239265 0
Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone)
Ethics committee address [1] 239265 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 239265 0
Australia
Date submitted for ethics approval [1] 239265 0
Approval date [1] 239265 0
26/02/2009
Ethics approval number [1] 239265 0
X08-0316

Summary
Brief summary
This study evaluates the effectiveness of surgery in treating residual disease in patients with metastatic gastrointestinal stromal cell tumours who are responding to treatment with imatinib mesylate. Patients will be randomly divided into two groups. One group will receive surgery to remove residual disease and continue imatinib therapy. The other group will receive continued imatinib therapy only. Participants will be monitored twice in first 6 months, then every 3 months for the first 5 years, and then every 6 months until any progression of disease.

Who is it for?
-Patients with metastatic GIST.
-Patients who have taken 6-12 months of imatinib mesylate.
-Patients with either stable disease or tumour regression since the start of imatinib mesylate.
Trial website
http://www.gicancer.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29757 0
Address 29757 0
Country 29757 0
Phone 29757 0
Fax 29757 0
Email 29757 0
Contact person for public queries
Name 13004 0
Karen Bracken
Address 13004 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country 13004 0
Australia
Phone 13004 0
+61 2 9562 5071
Fax 13004 0
+ 61 2 9562 5094
Email 13004 0
[email protected]
Contact person for scientific queries
Name 3932 0
Karen Bracken
Address 3932 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
NSW 1450
Country 3932 0
Australia
Phone 3932 0
+61 2 9562 5071
Fax 3932 0
+ 61 2 9562 5094
Email 3932 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
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