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

NCT04097093 | Withdrawn

• 1 other identifier: EORTC 1826-STBSG
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GIST

Outcome Measures

Primary Outcomes (5)

• Patient characteristics

  Age at time of randomization, gender, medical history and previous treatment(s)

  At time of registration

• Tumour characteristics

  Stage of the disease, tumor grade, tumor location and molecular features of primary tumor

  At time of registration

• Duration of imatinib treatment

  Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment

  At time of registration

• Health releated quality of life

  QLQ-C30

  At time of registration

• Overall survival

  From time of randomization to the date of death, whatever the cause

  At time of registration

Study Arms (1)

Study 62005-STBSG patients treated with imatinib > 10 years

Other: No intervention

Interventions

No intervention OTHER

No intervention

Study 62005-STBSG patients treated with imatinib > 10 years

Eligibility Criteria

• Age: 28 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Able to read and answer questionnaires
• Able to provide written informed consent

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Biospecimen

Retention: SAMPLES WITH DNA

First, existing data on molecular characteristics of included patients will be collected from the treating centers. If more than 40% of the data is not available, archival tumor tissue from patients enrolled in the EORTC 62005-STBSG study will be collected and used to identify molecular characteristics of the tumor that may predict long-term response to imatinib. Archival tumor tissues will be retrieved from the central lab of the study 62005-STBSG (UZ Leuven, Belgium) or from the sites (if applicable).

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 20, 2019
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share