A Phase 2 Study of 5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk of Recurrence Following Surgical Resection
In this study, the investigators aim to investigate the efficacy and safety of 5 years of adjuvant imatinib treatment in patients with tumor rupture defined by Nishida classification or those with a tumor size 10cm or larger and a mitotic index of 10/50HPFs or higher.
⁃ Age 20 years or older, at the time of acquisition of informed consent
⁃ Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
⁃ (1) Completely resected localized GIST (R0 resection) within 12 weeks prior to the start of the adjuvant imatinib.
• (2) After complete resection(R0 resection), High risk GIST according to Modified NIH criteria and ongoing adjuvant imatinib treatment.
• 4\) High risk GIST according to Modified NIH criteria,
⁃ Tumor rupture according to Nishida classification or
⁃ tumor size \>10cm and mitosis \>10/50 HPF 5) Eastern Cooperative Oncology Group (ECOG) performance status 0 \
• 2 6) Adequate bone marrow, hepatic, renal, and other organ functions, before adjuvant imatinib treatment
∙ Neutrophil \>1,500/mm3
‣ Platelet \> 100,000/mm3
‣ Hemoglobin \>8.0 g/dL
‣ Total bilirubin \< 1.5 x upper limit of normal (ULN)
‣ AST/ALT \< 2.5 x ULN
‣ Creatinine \<1.5 x ULN 7) Provision of a signed written informed consent