GastroIntestinal Stromal Tumours (GIST) MedDRA version: 16.1 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Glivec
Product Name: Imatinib
Pharmaceutical Form: Tablet
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
CENTRE LEON BERARD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1.Age = 18 years at the day of consenting to the study I2.Patients must have histologically confirmed diagnosis of localized GIST with documented KIT (CD117) positivity (by polyclonal DAKO antibody staining) I3.Documented macroscopically complete surgical R0 or R1 resection of primary GIST lesion with no evidence of residual lesions or metastases on the baseline CT-scan or MRI performed no more than 4 weeks before randomization. I4.Risk of tumor recurrence =35% according to National Comprehensive Cancer Network Task Force on GIST (NCCN) risk classification (Demetri et al., 2010) (adapted from Miettinen and Lasota, Seminars in Diagnostic Pathology 2006: 23(2) 70-83) I5.ECOG performance status 0, 1 or 2 I6.Patients must be under imatinib treatment (at 300 or 400mg/day) initiated immediately after resection and maintained for 3 years (i.e. 36 months ± 3 months at the time of randomization) with no more than 3 consecutive months or 6 months in total of interruption during these 3 years. I7.Patients must have normal organ and bone marrow function at baseline as defined below: •Adequate bone marrow function as defined by: ANC = 1.5 x 109/L, platelet count = 100.0 x 109/L, and haemoglobin of = 9 g/dL). •Adequate liver function, as determined by: Serum total bilirubin = 1.5 ULN, AST and ALT = 3 x ULN (or 5ULN in case of hepatic metastases at time of reintroduction) •Adequate renal function assessed by at least one of the following: 1) Serum creatinine = 1.5 x ULN or 2) creatinine clearance estimate = 50 mL/min (as calculated according to Cockcroft-Gault formula or MDRD formula for patients > 65 years). I8.Recovered from prior anti-neoplasic treatment-related toxicity (persistent treatment-related toxicity =65 years) yes F.1.3.1 Number of subjects for this age range 256
Exclusion criteria
Exclusion criteria: E1. Pregnant or breastfeeding women E2. Patient concurrently using other approved or investigational antineoplastic agents E3. Any contra-indication to imatinib treatment as per Glivec® SPC E4. Patient with GIST harboring the mutation ; PDGFRa d842V E5. Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient’s participation in this trial or would likely interfere with study procedures or results E6. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years E7. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications E8. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) E9. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection E10. Major surgery within 2 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical impact, of maintenance versus interruption of imatinib adjuvant treatment beyond 3 years, in patients with resected primary GIST with high risk of recurrence;Secondary Objective: •To assess overall survival •To assess safety and tolerance of imatinib treatment •To assess time to secondary resistance •To evaluate the rate of patients in complete response (as per RECIST 1.1) after reintroduction of imatinib in case of GIST recurrence in the "interruption" arm To assess quality of life;Primary end point(s): Disease-Free survival;Timepoint(s) of evaluation of this end point: 3 years post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Time to second resistance Percentage of patients in complete response Quality of life;Timepoint(s) of evaluation of this end point: Overall survival, time to second resistance, percentage of patients in complete response : 3 years post-randomization Quality of life : baseline, 1, 2 and 3 years post-randomization and in case of progression | — |
Countries
France
Contacts
Public ContactGWENAELE GARIN
CENTRE LEON BERARD
Outcome results
None listed