Actively Recruiting
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
Led by Asan Medical Center · Updated on 2025-08-08
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of 5 years of adjuvant imatinib treatment in patients with gastrointestinal stromal tumors (GIST) who have a high risk of recurrence. This includes patients with tumor rupture defined by Nishida classification or those with tumors 10cm or larger and a high mitotic index. The study builds on previous findings that showed benefits of shorter imatinib treatment durations and aims to improve long-term outcomes for high-risk patients. Participants will receive imatinib mesylate orally at a dose of 400 mg once daily for 5 years. This treatment extends the current standard 3-year adjuvant therapy by an additional 2 years. The study focuses on patients who have had complete surgical removal of their tumor and meet specific high-risk criteria. The trial is a phase 2, open-label study without randomization or placebo. Throughout the 5-year treatment period, participants will be monitored for progression-free survival as the primary outcome. Researchers will assess tumor status and overall health through regular visits and laboratory tests to evaluate safety and response. The study will also monitor organ function and patient performance status to ensure ongoing suitability for treatment. Participation may last up to 5 years, including follow-ups to observe long-term effects of the therapy.
CONDITIONS
Brief 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 PDGFRα gene
- Completely resected localized GIST (R0 resection) within 12 weeks prior to start of 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 and mitotic count over 10/50 HPF
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver, kidney, and other organ function
- Signed written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Women or men unwilling to use effective contraception during the study and for 3 months after last drug dose
- Recent (within 6 months) serious heart conditions including myocardial infarction, unstable angina, bypass surgery, severe heart failure, stroke, or severe arrhythmia
- Uncontrolled infections
- Acute or chronic liver disease or impairment (except stable chronic hepatitis B)
- Previous imatinib dose reduced below 300 mg/day due to toxicity
- Active uncontrolled medical or psychiatric conditions or lab abnormalities
- Known HIV infection
- History of other clinically significant primary malignancy requiring active treatment
- Alcohol or substance abuse disorder
- Patients with PDGFRα D842V mutation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years
Participants receive oral imatinib mesylate once daily as adjuvant therapy following surgical resection of gastrointestinal stromal tumor.
Regular visits for monitoring and medication dispensing during the 5 years
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
K
Kang Yoon-Koo, MD, PhD
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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