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Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation

NCT00278876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-01-07

Study results available
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Summary

The presence of c-kit mutation is an independent poor prognostic factor for relapse in addition to large size (\> 5 cm) and high mitotic rate (\> 5/50 high power field \[HPF\]) in localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of high-risk for relapse according to National Institute of Health (NIH) consensus guideline (tumor size \> 10 cm or mitotic count \> 10/50 HPF) also have high-risk of relapse. Until recently, there has been no effective therapy for advanced, unresectable GISTs. However, a new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11 mutation is the strongest prognostic factor for better response and survival. It is reasonable to try imatinib in an earlier and minimal residual status especially for patients at higher risk of relapse and a higher probability of response to imatinib.

Conditions

Interventions

DRUG

Imatinib mesylate (Glivec)

Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yoon-Koo Kang, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-08-31
Completion
2011-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278876 on ClinicalTrials.gov