Long-term Survivorship Challenges of Advanced/Metastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study

Recruiting now

Conditions studied: Gastrointenstinal Stromal Tumor (GIST)

In brief

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. Participants will include adults with advanced or metastatic GIST who have received TKI therapy for at least 2 years. Data will be collected from medical records and through validated patient-reported outcome questionnaires at baseline and annually for up to 10 years. This study aims to provide insight into HRQoL problems, treatment discontinuation, coping strategies, and the impact of financial toxicity among long-term survivors of GIST.

Key facts

Study ID

NCT07522762

Run by

The Netherlands Cancer Institute

People needed

330

Starts

2025-05-21

Expected to finish

2037-05-21

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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