Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00103168
Registration number
NCT00103168
Ethics application status
Date submitted
7/02/2005
Date registered
8/02/2005
Date last updated
9/07/2018
Titles & IDs
Public title
Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor
Query!
Scientific title
Intermediate and High Risk Localized, Completely Resected, Gastrointestinal Stromal Tumors (GIST) Expressing KIT Receptor: A Controlled Randomized Trial on Adjuvant Imatinib Mesylate (Glivec) Versus No Further Therapy After Complete Surgery
Query!
Secondary ID [1]
0
0
EORTC-62024
Query!
Secondary ID [2]
0
0
EORTC-62024
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumor
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Stomach
Query!
Cancer
0
0
0
0
Query!
Bowel - Small bowel (duodenum and ileum)
Query!
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - imatinib mesylate
Experimental: Imatinib mesylate - 400 mg/day for 2 years
No Intervention: Control -
Treatment: Drugs: imatinib mesylate
400 mg/day for 2 years
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall survival
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Secondary outcome [1]
0
0
Relapse-free survival
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Secondary outcome [2]
0
0
Relapse-free interval
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Query!
Secondary outcome [3]
0
0
Adverse events
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Query!
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed gastrointestinal stromal tumor
- Localized disease
- Meets 1 of the following criteria:
- At high-risk of relapse, defined by 1 of the following criteria:
- Tumor size > 10 cm
- Mitotic rate > 10/50 high-power field (HPF)
- Tumor size > 5 cm AND mitotic rate > 5/50 HPF
- At intermediate-risk of relapse, defined by 1 of the following criteria:
- Tumor size < 5 cm AND mitotic rate 6-10/50 HPF
- Tumor size 5-10 cm AND mitotic rate < 5/50 HPF
- Tumor must stain positive for Kit (CD117) by polyclonal DAKO antibody staining
- Must have undergone complete resection of the primary tumor at least 2 weeks, but no
more than 3 months, before study entry
- Meets criteria for 1 of the following resection levels:
- R0 (clear margins)
- R1, defined by 1 of the following criteria:
- Margins of resection are contaminated by tumor, but no macroscopic
tumor is left behind
- Intraoperative tumor rupture
- Shelling-out procedure
- Endoscopic maneuver
- No residual macroscopic disease after surgery
- Regional positive lymph nodes allowed provided they have been
macroscopically excised
- No distant metastases*, including any of the following:
- Peritoneal lesion not contiguous to the primary tumor
- Liver metastases
- Hemoperitoneal metastases NOTE: *Even if a complete resection (R0) was performed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count = 1,500/mm^3
- Platelet count = 100,000/mm^3
- Hemoglobin = 9 g/dL (transfusions allowed)
Hepatic
- Bilirubin = 1.5 times upper limit of normal (ULN)
- AST or ALT = 2.5 times ULN
- No uncontrolled liver disease
- No chronic viral hepatitis at risk of reactivation
Renal
- Creatinine < 1.5 times ULN
- No uncontrolled chronic renal disease
Cardiovascular
- No New York Heart Association class III-IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 2 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 3 months after
study participation
- No uncontrolled diabetes
- No uncontrolled active infection
- No HIV infection
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance or participation
- No other severe and/or uncontrolled medical disease
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other prior molecular targeted or biologic therapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
- No concurrent anticancer biologic agents
Chemotherapy
- No prior chemotherapy for gastrointestinal stromal tumors
- No concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
- No concurrent anticancer radiotherapy
Surgery
- See Disease Characteristics
- Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or
emergency surgery with symptomatic intent)
Other
- No prior imatinib mesylate
- No prior randomization to this study
- No concurrent therapeutic anticoagulation with coumarin derivatives
- Concurrent therapeutic low-molecular weight heparin or mini-dose coumarin
derivatives (equivalent to oral warfarin 1 mg/day) allowed for prophylaxis of
central venous catheter thrombosis
- No other concurrent antitumoral therapy
- No other concurrent anticancer agents
- No other concurrent investigational drugs
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
120
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
908
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment outside Australia
Country [1]
0
0
Denmark
Query!
State/province [1]
0
0
Herlev
Query!
Country [2]
0
0
France
Query!
State/province [2]
0
0
Abbeville
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Angers
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Besancon
Query!
Country [5]
0
0
France
Query!
State/province [5]
0
0
Bobigny
Query!
Country [6]
0
0
France
Query!
State/province [6]
0
0
Bordeaux
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Boulogne Billancourt
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Brest
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Caen
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Clermont-Ferrand
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Colmar
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Dijon
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Dreux
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Le Chesnay
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Le Mans
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Libourne
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Lille
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Lyon
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Marseille
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Mont-de-Marsan
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Montpellier
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Nantes-Saint Herblain
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Nantes
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Orleans
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Pau
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Reims
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Rennes
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Rouen
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Saint Cloud
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Saint Priest en Jarez
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Strasbourg
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Toulouse
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Vandoeuvre-les-Nancy
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Villejuif
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Tuebingen
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Leon
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Madrid
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
England
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Scotland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
European Organisation for Research and Treatment of Cancer - EORTC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Italian Sarcoma Group
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
UNICANCER
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Grupo Espanol de Investigacion en Sarcomas
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining
tumor cells. It is not yet known whether imatinib mesylate is more effective than observation
only in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it
works compared to observation only in treating patients who have undergone surgery for
localized gastrointestinal stromal tumor.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00103168
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Paolo G. Casali, MD
Query!
Address
0
0
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00103168
Download to PDF