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

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ClinicalTrials.gov Identifier: NCT04097093
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 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

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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 : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Primary site [ Time Frame: 1 year from first patient in ]
    Site of primary tumor (Oesophagus, cardia, stomach, duodenum, small intestine, colon, rectum, other, unknown)

  2. Primary tumor grade [ Time Frame: 1 year from first patient in ]
    Primary tumor grade according to mitoses (reported per 50 HPF or per 5 mm2)

  3. Primary tumor stage [ Time Frame: 1 year from first patient in ]
    Pirmary tumor stage in diameter (reported in cm)

  4. Mutational status [ Time Frame: 1 year from first patient in ]
    Mutational status of the primary tumor

  5. Metastases [ Time Frame: 1 year from first patient in ]
    Localisation of metastases

  6. Previous systemic treatments [ Time Frame: 1 year from first patient in ]
    Number of lines of previous systemic treatments

  7. WHO performance status [ Time Frame: 1 year from first patient in ]
    WHO performance status of patient at initiation of imatinib

  8. Imatinib treatment [ Time Frame: 1 year from first patient in ]
    Total duration of imatinib treatment

  9. Response [ Time Frame: 1 year from first patient in ]
    Best response during imatinib treatment according to RECIST1.1


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).


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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
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Contact: EORTC HQ +32 2 774 1611 1826@eortc.org

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Neeltje Steeghs NKI - Antoni van Leeuwenhoekziekenhuis
Study Chair: Axel Le Cesne Gustave ROUSSY
Study Chair: Ingrid Desar Radboud University Medical Center Nijmegen
Study Chair: Olga Husson Radboud University Medical Center Nijmegen

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action