Living long-term with advanced GIST on tyrosine kinase inhibitors

Long-term Survivorship Challenges of Advanced/Metastatic GIST Patients Responding to Tyrosine Kinase Inhibitor Treatment: an Observational Study (EORTC-1944)

This observational project will collect medical records and patient questionnaires to see how long-term tyrosine kinase inhibitor treatment affects quality of life and survivorship for adults with advanced or metastatic GIST who have taken TKIs for at least two years.

Quick facts

• Study type: Observational
• Enrollment: 330 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Netherlands Cancer Institute (other)
• Drugs / interventions: sunitinib, avapritinib, ripretinib, imatinib
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT07522762 on ClinicalTrials.gov

What this trial studies

This is an international, multicentre observational program with two parts: a retrospective cross-sectional component and a prospective cohort (registry). The retrospective arm focuses on patients with unresectable or metastatic GIST treated with TKIs for five years or more to test the relevance and applicability of patient-reported outcome instruments and identify GIST-specific survivorship issues. The prospective cohort enrolls adults with advanced or metastatic GIST who have received TKIs for at least two years across multiple centres in Europe and China and follows them over time. Data collection combines validated questionnaires on health-related quality of life, coping, and financial impact with clinical information extracted from medical records to document long-term outcomes, treatment patterns, and survivorship challenges.

Who should consider this trial

Good fit: Adults with histologically confirmed advanced or metastatic GIST who have been on continuous TKI therapy for at least two years and can read questionnaires and give informed consent.

Not a fit: Patients receiving TKIs only in the adjuvant setting, those too ill for follow-up, or those unable to complete questionnaires are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this work could help clinicians and patients recognize and address long-term quality-of-life issues and treatment burdens for people living with advanced GIST on chronic TKIs.

How similar studies have performed: Related patient-reported outcome and survivorship research in oncology and among TKI-treated groups exists, but long-term, multicentre GIST-specific survivorship data are limited, making this effort partly novel.

Eligibility criteria

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.

Where this trial is running

Amsterdam, North Holland

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

Study contacts

• Principal investigator: Winette V van der Graaf, Prof. dr. — Antoni van Leeuwenhoek
• Study coordinator: Tessa van Amerongen, MSc, Drs.

Conditions: Gastrointenstinal Stromal Tumor, Gastrointestinal Stromal Tumor, Tyrosine Kinase Inhibitor, Imatinib, Health-related quality of life, Metastatic disease