Actively Recruiting
5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
Led by Asan Medical Center · Updated on 2025-08-08
35
Participants Needed
1
Research Sites
398 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at the time of informed consent
- Histologically confirmed GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRA gene
- Completely resected localized GIST (R0 resection) within 12 weeks prior to starting adjuvant imatinib
- High risk GIST according to Modified NIH criteria with ongoing adjuvant imatinib treatment
- Tumor rupture by Nishida classification or tumor size larger than 10 cm with mitosis over 10/50 high-power fields
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate bone marrow, liver, kidney, and other organ functions before starting adjuvant imatinib
- Provision of signed written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Women or men not willing to use effective contraception during the study and for 3 months after last dose
- History within 6 months before enrollment of myocardial infarction, severe unstable angina, coronary or peripheral bypass, severe heart failure (NYHA class III or IV), stroke or transient ischemic attack, or severe arrhythmia requiring treatment
- Uncontrolled infection
- Acute or chronic liver disease or impairment (except stable chronic hepatitis B)
- Dose of imatinib reduced below 300 mg/day due to toxicity
- Acute or chronic medical or psychiatric conditions or lab abnormalities that make study participation difficult
- Known HIV infection
- History of another primary malignancy requiring active treatment
- Alcohol or substance abuse disorder
- Presence of PDGFRA D842V mutation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, South Korea, 138-736
Actively Recruiting
Research Team
R
Ryu Min-Hee, MD, PhD
CONTACT
K
Kang Yoon-Koo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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