Status:
RECRUITING
5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
Lead Sponsor:
Asan Medical Center
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
Localized resectable GISTs can be cured with surgical resection, but no effective therapy had been established for patients with unresectable and/or metastatic GISTs and their prognosis was extremely ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05385549
Start Date
September 7 2022
End Date
April 30 2030
Last Update
August 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, South Korea, 138-736