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

NCT ID: NCT04097093

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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GIST

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study 62005-STBSG patients treated with imatinib > 10 years

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neeltje Steeghs

Role: STUDY_CHAIR

NKI - Antoni van Leeuwenhoekziekenhuis

Axel Le Cesne

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Ingrid Desar

Role: STUDY_CHAIR

Radboud University Medical Center Nijmegen

Olga Husson

Role: STUDY_CHAIR

Radboud University Medical Center Nijmegen

Other Identifiers

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EORTC 1826-STBSG

Identifier Type: -

Identifier Source: org_study_id

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