SSG XXV: The Stop-GIST Trial; Discontinuation of Imatinib in Patients With Oligo-metastatic 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: NCT02924714|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : April 10, 2018
|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
|Contact: Øyvind S Bruland, MD PhD||22934767 ext email@example.com|
|Contact: Ivar Hompland, MD||22931236 ext firstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Contact: Øyvind S Bruland|
|Principal Investigator: Øyvind S Bruland|
|Study Director:||Heikki Joensuu, MD PhD||Comprehensive Cancer Center Helsinki|
|Principal Investigator:||Øyvind S Bruland, MD PhD||Oslo University Hospital|