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

GIST Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04097093
• Other study ID #: EORTC 1826-STBSG
• Status: Withdrawn
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GIST

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics	Age at time of randomization, gender, medical history and previous treatment(s)	At time of registration
Primary	Tumour characteristics	Stage of the disease, tumor grade, tumor location and molecular features of primary tumor	At time of registration
Primary	Duration of imatinib treatment	Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment	At time of registration
Primary	Health releated quality of life	QLQ-C30	At time of registration
Primary	Overall survival	From time of randomization to the date of death, whatever the cause	At time of registration