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

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04097093
• Collaborator: (none)
• Enrollment: 0
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GIST	Other: No intervention

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
• Anticipated Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient characteristics [At time of registration]

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

2. Tumour characteristics [At time of registration]

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

3. Duration of imatinib treatment [At time of registration]

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

4. Health releated quality of life [At time of registration]

   QLQ-C30

5. Overall survival [At time of registration]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
• ClinicalTrials.gov Identifier: NCT04097093
• Other Study ID Numbers: EORTC 1826-STBSG
• First Posted: Sep 20, 2019
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 2, 2020