Gastrointestinal Stromal Tumor (GIST)
Conditions
Interventions
Neoadjuvant imatinib (400 mg/day) for 6 months (24 weeks) + Gastrectomy + Adjuvant imatinib (400 mg/day) for 12 months (48 weeks)
Sponsors
Japanese Study Group on GIST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are histopathologically diagnosed as GIST 2)Patients with GIST of stomach origin 3)Patients with tumor diameter of 10 cm or more which is identified by abdominal CT 4)Patients who have neither apparent distant metastasis nor peritoneal metastasis 5)Patients with first onset of GIST 6)Patients who have not undergone any treatment including surgery, chemotherapy, and radiotherapy for the disease 7)Patients who take food orally 8)Patients who are at least 20 years old and less than 80 years old 9)Patients whose Performance Status (ECOG) is 0 or 1 10)Patients with the following organ function 11)Patients who submit written consent forms for the study participation
Exclusion criteria
Exclusion criteria: 1)Patients who have a medical history of active double cancers in the past 5 years 2)Patients who have a medical history of GIST 3)Patients who have heart disease of NYHA (New York Heart Association) class III or IV 4)Patients who are pregnant, lactating, or with the intention of becoming pregnant (including men) 5)Patients who have uncontrollable diseases or serious complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), Progression-free Survival (PFS), objective response rate, pathological response rate, rate of stomach preservation, treatment completion rate, incidence rate of adverse events, imatinib plasma level | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactYukinori Kurokawa
Osaka University Department of Gastroenterological Surgery
Outcome results
None listed