Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097093
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
GIST Other: No intervention

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Imatinib

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




Primary Outcome Measures :
  1. Patient characteristics [ Time Frame: At time of registration ]
    Age at time of randomization, gender, medical history and previous treatment(s)

  2. Tumour characteristics [ Time Frame: At time of registration ]
    Stage of the disease, tumor grade, tumor location and molecular features of primary tumor

  3. Duration of imatinib treatment [ Time Frame: At time of registration ]
    Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment

  4. Health releated quality of life [ Time Frame: At time of registration ]
    QLQ-C30

  5. Overall survival [ Time Frame: At time of registration ]
    From time of randomization to the date of death, whatever the cause


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).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   28 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097093


Contacts
Layout table for location contacts
Contact: EORTC HQ +32 2 774 1611 1826@eortc.org

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT04097093    
Other Study ID Numbers: EORTC 1826-STBSG
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No