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Long-term Surival of GIST Patients ≥ 10 Years on Imatinib

Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04097093
Enrollment
0
Registered
2019-09-20
Start date
2020-06-01
Completion date
2021-06-01
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GIST

Brief summary

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
28 Years to No maximum
Healthy volunteers
No

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: 1. Able to read and answer questionnaires 2. Able to provide written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Patient characteristicsAt time of registrationAge at time of randomization, gender, medical history and previous treatment(s)
Tumour characteristicsAt time of registrationStage of the disease, tumor grade, tumor location and molecular features of primary tumor
Duration of imatinib treatmentAt time of registrationTime on imatinib treatment from start untill definitive discontinuation of imatinib treatment
Health releated quality of lifeAt time of registrationQLQ-C30
Overall survivalAt time of registrationFrom time of randomization to the date of death, whatever the cause

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026