Long-term Surival of GIST Patients ≥ 10 Years on Imatinib
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.
This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.
Patient characteristics [ Time Frame: At time of registration ]
Age at time of randomization, gender, medical history and previous treatment(s)
Tumour characteristics [ Time Frame: At time of registration ]
Stage of the disease, tumor grade, tumor location and molecular features of primary tumor
Duration of imatinib treatment [ Time Frame: At time of registration ]
Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment
Health releated quality of life [ Time Frame: At time of registration ]
Overall survival [ Time Frame: At time of registration ]
From time of randomization to the date of death, whatever the cause
Biospecimen Retention: Samples With DNA
First, existing data on molecular characteristics of included patients will be collected from the treating centers. If more than 40% of the data is not available, archival tumor tissue from patients enrolled in the EORTC 62005-STBSG study will be collected and used to identify molecular characteristics of the tumor that may predict long-term response to imatinib. Archival tumor tissues will be retrieved from the central lab of the study 62005-STBSG (UZ Leuven, Belgium) or from the sites (if applicable).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
28 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.
Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
Patients who have been treated with imatinib for ten years or longer