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

Withdrawn

• Conditions: GIST
• Interventions: Other: No intervention

• Registration Number: NCT04097093
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2020-06-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study 62005-STBSG patients treated with imatinib > 10 years	No intervention	-

Primary Outcome Measures

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