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Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)

Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST) - Effect of Imatinb in the adjuvant setting on patients with resectable Gastrointestinal Stromal Tumour (GIST)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004989
Enrollment
40
Registered
2011-02-01
Start date
2010-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumor (GIST)

Interventions

To examine gene-mutation of resected tumor cell

Sponsors

Kochi Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients pathologically diagnosed as GIST 2.Patients with KIT positive by immunohistological study 3.Patients who were macroscopically 4.Intermediate or High risk (including clinically malignant) classified by Fletcher category 5.Age: ≥>=20 & <75 6.Patients who have no previous treatment 7.Patients who could start adjuvant treatment within 2-12 weeks 8.PS(ECOG):0-2 9.Patients who To be able to take orally 10.Patients who Maintain major organ function (2 weeks after surgery & 30 days before submission) 11.Patients who acquire agreement by written document

Exclusion criteria

Exclusion criteria: 1.Patients who have a medical history of active double cancers without cis in the past 5 years 2.Patients who have active infectious disease by bacteria and/or fungus 3.Patients who have heart disease of NYHA class III or IV 4.Patients who are pregnant, lactating, or with the intention of becoming pregnant (including men) 5.Patients who have mental disorder and considered inappropriate for registration to this study 6.Patients who were judged to be unacceptable for enrollment by investigators.

Design outcomes

Primary

MeasureTime frame
Recurrence-Free Survival (RFS)

Secondary

MeasureTime frame
1.Accomplishment rate of treatment 2.Overall survival (OS) 3.To examine factors for Imatinib treatment continuation 4.Relationship between mutation and survival term (RFS, OS) 5.Occurrence rate of adverse events

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026