Gastrointestinal stromal tumors (GIST) are mesenchymal neoplasms usually arising from the gastrointestinal wall. Pathologically,they present with spindle cells in most cases. Immunohistochemically, GIST cells are almost always positive for CD117.CD117 corresponds to the KIT receptor, a tyrosine kinase receptor which is altered in GIST due to a mutation to the c-kit oncogene. This event is held to be critical for GIST pathogenesis. MedDRA version: 14.1 Level: PT Classification code 10051066 Te
Conditions
Interventions
Trade Name: GLIVEC
Product Name: Glivec
Product Code: STI571
Pharmaceutical Form: Capsule
INN or Proposed INN: Imatinib mesylate
CAS Number: 220127-57-1
Current Sponsor code: STI571
Concentration unit
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117) ? Risk of relapse documented on the surgical specimen, according to the 2002 Consensus Approach to Diagnosis of GIST (See Appendix H and Ref. 7), as falling within the “high-risk” category (tumor size >10 cm; or mitotic rate >10/50HPF; or tumor size >5 cm & mitotic rate >5/50HPF) or the “intermediate-risk” category (tumor size 18 yrs. ? WHO PS = 0-2 (see Appendix B) ? The cardiac ejection function will be assessed at baseline. The choice of the method is left to physician’s discretion (LVEF (MUGA or ECHO), NT-proBNP….). An ECG must also be performed. No Class 3/4 cardiac problems, as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study; see Appendix C) ? Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis, judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.). ? No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease-free for >5 years. ? No ongoing pregnancy or nursing. Women/men of reproductive potential must agree to use an effective contraceptive method throughout the treatment period and for up to 3 months following discontinuation of the drug. Women of reproductive potential must have a negative pregnancy test within 7 days prior to treatment start. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether Imatinib mesylate, as an adjunct to complete surgery, is able to improve prognosis of patients with intermediate and high-risk, localized GIST.;Secondary Objective: To assess whether there is a difference in relapse-free survival and relapse-free interval between intermediate and high-risk localized GIST patients undergoing complete surgery alone and those undergoing complete surgery plus adjuvant Imatinib mesylate 400 mg daily for two years. To assess safety of Imatinib mesylate given as an adjuvant to complete surgery in intermediate-risk and high-risk local GIST patients.;Primary end point(s): Imatinib monotherapy failure free survival;Timepoint(s) of evaluation of this end point: Assessed at follow-up visits. Patients in treatment arm will be followed every week for the first month, then every 2 weeks for the second month, then monthly until the end of the 6th month of therapy, and subsequently every 3 months until treatment discontinuation. Patients in the control arm and patients in the treatment arm who have completed treatment are followed every 3 months until 2 years from randomization have elapsed, then every 4 months until 5 years have elapsed, and thereafter at least annually, at the discretion of the responsible physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Relapse-free survival; 2) Relapse-free interval; 3) Overall survival; 4) Adverse events;Timepoint(s) of evaluation of this end point: Assessed at follow-up visits. Patients in treatment arm will be followed every week for the first month, then every 2 weeks for the second month, then monthly until the end of the 6th month of therapy, and subsequently every 3 months until treatment discontinuation. Patients in the control arm and patients in the treatment arm who have completed treatment are followed every 3 months until 2 years from randomization have elapsed, then every 4 months until 5 years have elapsed, and thereafter at least annually, at the discretion of the responsible physician. | — |
Countries
Denmark, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactProject, Budget and Regulatory Depa
European Organisation for Research and Treatment of Cancer
Outcome results
None listed