Gastrointestinal stromal tumor (GIST)
Conditions
Interventions
Imanitib 400 mg/day for 1 year
Imanitib 400 mg/day for 6 months
Sponsors
Kinki GIST Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A confirmed diagnosis of GIST by immunohistochemical test using resected sample or gene mutation test 2) Judgement as being at intermediate or high risk (including clinical malignant) according to risk stratification criteria 3) New-onset lesions (regardless of their primary sites) 4) Macroscopic curative resection (R0 or R1) has been carried out. 5) Judgement as being able to receive imanitib therapy within 12 weeks after surgery 6) Adequate organ function defined as indicated by the following blood test findings obtained within 4 weeks before enrollment Neutrophils count: >=1,500/mm3 Platelet count: >=100,000/mm3 Total bilirubin: <=1.5 times the upper limit of normal (ULN) AST(sGOT): <=2.5 times the ULN ALT(sGPT): <=2.5 times the ULN Creatinine: <=1.5 times the ULN 7) An ECOG performance status of 0 or 1 8) Age 20 to <80 years old 9) Written informed consent by the patient to participation in the study
Exclusion criteria
Exclusion criteria: 1) Familial GIST or GIST complicated with von Recklinghausen disease (NF type 1) 2) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years). Carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) that are judged as having been cured by local treatment is not included in active double cancer. 3) Prior chemotherapy, radiotherapy, or immunotherapy after resection of lesions 4) Prior treatment with imanitib 5) Cardiac disease assigned to NYHA class III or IV 6) Women who are pregnant, breast-feeding, or planning to become pregnant 7) Active mycosis and other infections 8) Other conditions judged as inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; treatment completion rate; the relationship of mutations of c-kit and PDGFRA as well as mRNA expression of their related factors to survival period (recurrence-free survival and overall survival); and adverse events | — |
Countries
Japan
Contacts
Public ContactYukinori Kurokawa
Osaka University Department of Gastroenterological Surgery
Outcome results
None listed