gastrointestinal stromal tumor (GIST)
Conditions
Interventions
Sponsors
Scandinavian Sarcoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Morphological and immunohistological documentation of GIST (immunostaining for KIT [CD117] and/or DOG-1 positive, or mutation of KIT or PDGFRA present in tumour tissue). 3. Macroscopically complete surgical resection of GIST (either R0 or R1 resection). 4. Mutation analysis of KIT and PDGFR genes has been carried out. 5. A high risk of GIST recurrence, either 1) gastric GIST with mitotic count >10/50 HPFs, or 2) non-gastric GIST with mitotic count >5/50 HPFs, or 3) tumour rupture Tumour rupture (spillage of the tumour contents into the abdominal cavity) may have occurred either before or at surgery. 6. ECOG performance status = 2. 7. Adequate organ function, defined as serum total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Presence of distant metastases or local recurrence of GIST. 2. Not willing to donate tumour tissue and/or blood samples for the study molecular studies. 3. Presence of a substitution mutation at PDGFRA codon D842 (usually D842V). 4. Administration of adjuvant imatinib longer than for 3 years is planned regardless of the result of randomisation, or “life long” imatinib administration is planned. 5. Prior adjuvant (+ neoadjuvant) therapy with imatinib mesylate for at least 35 months has not been completed, or the total duration of prior adjuvant (+ neoadjuvant) imatinib administration exceeds the total duration of 37 months. 6. Neoadjuvant imatinib for a duration that exceeds 9 months. 7. Longer than 4-week break during adjuvant imatinib administration. 8. The dose of imatinib at completion of 3 years of adjuvant imatinib was 200 mg per day or less or greater than 800 mg per day. 9. Patient has received any investigational anti-cancer agents during adjuvant imatinib or between completion of adjuvant imatinib and the date of randomisation. 10. Patient has been free of another malignancy for less than 5 years except if the other malignancy is not currently clinically significant nor requiring active intervention, or if the other malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Recent existence of any other malignant disease is not allowed. 11. Patient with Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study entry). 12. Female patients who are pregnant or breast-feeding. 13. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, severe chronic renal disease, or active uncontrolled infection). 14. Known diagnosis of human immunodeficiency virus (HIV) infection. 15. Patient with a significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Calculate the recurrence-free survival (RFS) after randomisation;Secondary Objective: 1. Calculate the overall survival 2. Calculate the GIST-specific survival 3. Assess the toxicity in patients treated with imatinib 4. Assess the Quality of life in patients treated with imatinib;Primary end point(s): Recurrence-free survival (RFS) ;Timepoint(s) of evaluation of this end point: Defined by the time interval between the date of randomisation and the date of first detection of GIST recurrence or death, whichever occurs first. CT/MRI at 6-month intervals during the first 5 years on study in each arm, and then annually. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. GIST-specific survival 3. Safety 4. Quality of Life;Timepoint(s) of evaluation of this end point: 1. The time period between the date of randomisation and the date of death. 2. The time period between the date of randomisation and the date of death considered to be caused by GIST; patients who die from other causes are censored on the date of death. 3. Common Terminology Criteria for Adverse Events [CTCAE] version 3.0 collected every 3 months from randomisation 4. Quality of Life (EQ-5D instrument) collected every 3 months from randomisation | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Contacts
Public ContactSSG secretariat
Scandinavian Sarcoma Group
Outcome results
None listed