Long-term Survivorship Challenges of Advanced/Metastatic GIST Patients Responding to Tyros
Gastrointestinal stromal tumours (GISTs) are rare malignancies arising along the gastrointestinal tract. Tyrosine kinase inhibitors (TKIs) have substantially improved survival for patients with unresectable or metastatic GIST. As a result, an increasing number of patients live with advanced disease under chronic TKI th
| Condition(s) | Gastrointenstinal Stromal Tumor (GIST) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Gastrointestinal stromal tumours (GISTs) are rare malignancies arising along the gastrointestinal tract. Tyrosine kinase inhibitors (TKIs) have substantially improved survival for patients with unresectable or metastatic GIST. As a result, an increasing number of patients live with advanced disease under chronic TKI therapy, highlighting the need to understand long-term survivorship, including health-related quality of life (HRQoL), treatment burden, and clinical outcomes. This international, multicentre observational study includes two components: a retrospective cross-sectional study to evaluate the relevance and applicability of patient-reported outcome instruments, and a prospective cohort to document long-term clinical outcomes, HRQoL, treatment patterns, and survivorship challenges. |
| Who can participate | Inclusion Criteria: * Age 18 years or older (no upper age limit); * Advanced or metastatic GIST, diagnosis of GIST must be histologically proven; * Treated with TKIs (eg. sunitinib, regorafenib, avapritinib, ripretinib) for at least 2 years; TKI treatment ongoing; interruptions up to 3 months are allowed; * Able to read and answer questionnaires; * Able to provide informed consent. Exclusion Criteria: * Patients receiving TKI in an adjuvant treatment setting. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion the study. * Patients who are too ill (death is imminent), as determined by the referring health care professional |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The Netherlands Cancer Institute |
| Locations | Amsterdam, North Holland, Netherlands |
| Start date | 2025-05-21 |
| NCT ID | NCT07522762 |
| Official listing | https://clinicaltrials.gov/study/NCT07522762 |