SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic GIST
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|ClinicalTrials.gov Identifier: NCT02924714|
Recruitment Status : Suspended (Slow accrual)
First Posted : October 5, 2016
Last Update Posted : February 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Other: Discontinuation of imatinib||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Discontinuation of Imatinib in Patients With Oligo-metastatic Gastrointestinal Stromal Tumor That Has Become Radiologically Undetectable With Treatment|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Discontinuation of imatinib
Patients treated with imatinib longer than 5 years for oligo-metastatic GIST (≤ 3 metastases) and who have no longer detectable GIST lesions on CT/MRI imaging following complete surgical resection (R0/R1-resection) or RFA of the metastases are assigned to discontinue imatinib.
Other: Discontinuation of imatinib
- Progression free survival (PFS) [ Time Frame: 3 years ]Three-year progression-free survival (PFS) after discontinuation of imatinib.
- Overall survival (OS) [ Time Frame: 3 years ]Overall survival will be measured from the date of discontinuation of imatinib to the date of death resulting from any cause.
- Quality of Life (QoL) [ Time Frame: 3 years ]EQ-5D
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): NCT02924714
|Oslo University Hospital|
|Study Director:||Heikki Joensuu, MD PhD||Comprehensive Cancer Center Helsinki|
|Principal Investigator:||Øyvind S Bruland, MD PhD||Oslo University Hospital|