5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
Recruiting now · Phase 2
Conditions studied: Gastrointestinal Stromal Tumors
In brief
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.
Key facts
- Study ID
- NCT05385549
- Run by
- Asan Medical Center
- People needed
- 35
- Starts
- 2022-09-07
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2025-08-08
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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
You may not qualify if…
- Women of child-bearing potential who are pregnant or breast feeding
- Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.
- If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.
- Uncontrolled infection
- Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)
- Patients who had reduced the dose of imatinib to less than 300 mg/day due to toxicity.
- Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator
- Known diagnosis of HIV infection (HIV testing is not mandatory).
- History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Alcohol or substance abuse disorder.
- The patients with PDGFRα D842V mutation
Where it is running
- Asan Medical Center, University of Ulsan College of Medicine — Seoul, Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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