Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02413736|
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Imatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|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.
- Quality of life [ Time Frame: 5 years ]EQ-5D intrument.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|