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

September 1, 2020 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study 62005-STBSG patients treated with imatinib > 10 years
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Neeltje Steeghs, NKI - Antoni van Leeuwenhoekziekenhuis
  • Study Chair: Axel Le Cesne, Gustave Roussy, Cancer Campus, Grand Paris
  • Study Chair: Ingrid Desar, Radboud University Medical Center Nijmegen
  • Study Chair: Olga Husson, Radboud University Medical Center Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EORTC 1826-STBSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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