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
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|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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18.
- Morphological and immunohistochemical documentation of GIST (immunostaining for KIT/ (CD117) and/or DOG-1 (anoctamin-1)) must be positive on a tumour sample. Patients with demonstrated mutation in KIT or PDGFRA may be entered to the study despite negative immunostaining for KIT and DOG-1 provided that tumour histology is compatible with GIST.
- Confirmed metastatic disease by radiology, histology, or both in history.
- >5.0 years of treatment with imatinib for metastatic disease when the breaks in imatinib administration are taken into account.
- No more than 3 detectable metastases in the liver and/or in the abdomen on imaging of the abdomen and the pelvis or at surgery during the course of the disease.
- Macroscopically complete resection of all metastases (either R0 or R1 surgery). Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are eligible to enter the study. Radiofrequency ablation (RFA) of liver metastases in place of surgery is also allowed. Patients whose oligometastatic disease had disappeared completely so that no remaining target lesion for surgery or RFA can be identified (including absence of residual cyst-like lesions) are allowed to enter the study.
- Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2.
- Patient has provided a written, voluntary informed consent prior to study entry and any study-specific procedures.
- Patients with metastases outside of the abdomen (e.g. in the bones or lungs).
- Not willing to donate tumor tissue and/or blood samples for the molecular studies that aim at predicting of GIST recurrence.
- Presence of a mutation in SDH, or other evidence for SDH deficiency.
- Presence of neurofibromatosis-1.
- R2 resection of the primary tumour or metastasis.
- Patient with inability to grant reliable informed consent.
- Inability to comply with the scheduled follow-up.
Progressive disease during imatinib or other systemic treatments for GIST, before or after surgery/RFA of the metastases.
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|
|Responsible Party:||Øyvind Sverre Bruland, Professor in clinical oncology, Oslo University Hospital|
|Other Study ID Numbers:||
SSG XXV: Stop-GIST
|First Posted:||October 5, 2016 Key Record Dates|
|Last Update Posted:||February 18, 2022|
|Last Verified:||February 2022|
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action