Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lack of feasibility
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 62005-STBSG patients treated with imatinib > 10 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics | Age at time of randomization, gender, medical history and previous treatment(s) | At time of registration |
| Tumour characteristics | Stage of the disease, tumor grade, tumor location and molecular features of primary tumor | At time of registration |
| Duration of imatinib treatment | Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment | At time of registration |
| Health releated quality of life | QLQ-C30 | At time of registration |
| Overall survival | From time of randomization to the date of death, whatever the cause | At time of registration |
Not provided
Not provided
Inclusion Criteria:
Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST
Patients who have been treated with imatinib for ten years or longer
For the identified patients who are still alive:
Not provided
Not provided
Not provided
Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neeltje Steeghs | NKI - Antoni van Leeuwenhoekziekenhuis | Study Chair |
| Axel Le Cesne | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Ingrid Desar | Radboud University Medical Center Nijmegen | Study Chair |
| Olga Husson | Radboud University Medical Center Nijmegen | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).