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Three versus five years of adjuvant imatinib as treatment of patients with operable GIST with a high risk for recurrence: A randomised phase III study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512243-23-00
Enrollment
205
Registered
2024-10-03
Start date
2014-11-07
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

gastrointestinal stromal tumor

Brief summary

Recurrence-free survival (RFS). Defined by the time interval between the date of randomisation and the date of first detection of GIST recurrence or death, whichever occurs first. CT/MRI at 6-month intervals during the first 5 years on study in each arm, and then annually.

Detailed description

Overall survival., GIST-specific survival. The time period between the date of randomisation and the date of death considered to be caused by GIST; patients who die from other causes are censored on the date of death., Safety., Quality of Life

Interventions

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival (RFS). Defined by the time interval between the date of randomisation and the date of first detection of GIST recurrence or death, whichever occurs first. CT/MRI at 6-month intervals during the first 5 years on study in each arm, and then annually.

Secondary

MeasureTime frame
Overall survival., GIST-specific survival. The time period between the date of randomisation and the date of death considered to be caused by GIST; patients who die from other causes are censored on the date of death., Safety., Quality of Life

Countries

Austria, Denmark, Finland, Germany, Netherlands, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026