Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST
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|ClinicalTrials.gov Identifier: NCT02413736|
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Imatinib||Phase 3|
|Study Type :||Interventional|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2028|
|Estimated Study Completion Date :||May 2028|
Imatinib 400 mg/day for 24 months.
Imatinib 400 mg/day
Other Name: Gleevec
No Intervention: No imatinib
No further imatinib.
- Recurrence-free survival [ Time Frame: 5 years ]Time from the date of randomization to GIST recurrence or death.
- Overall survival [ Time Frame: 5 years ]Time from the date of randomization to death.
- GIST-specific survival [ Time Frame: 5 years ]Time from the date of randomization to the date of death considered to be caused by GIST.
- Adverse effects [ Time Frame: 5 years ]Adverse effects considered to be related to the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413736
|Contact: Heikki Joensuu, MD||094711 ext 358|
|Contact: Raija Husa||094711 ext 358|
|Helsinki University Central Hospital||Recruiting|
|Helsinki, Finland, 00029|
|Contact: Heikki Joensuu, MD 47173200 ext 09|
|Contact: Raija Husa|
|Principal Investigator:||Heikki Joensuu||Helsinki University Central Hospital|