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Completed

NCT Number: NCT03963544

Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (METAGIST)

Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases.

There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level.

Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting.

Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of patients outcome in terms of time to next treatment (TNT) and survival

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, 33076, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients ≥ 18 years old
  • with a diagnosis of metastatic Gastrointestinal Stromal Tumor (metastatic at diagnostic or metastatic relapse)
  • From 1990 to 2018

Exclusion criteria

-

Treatment and study plan

oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations

Drug

oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR

Primary outcomes

  1. Time to Next Treatment (TNT)

    Time frame: 10 years

    time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.

  2. Overall Survival (OS) Time

    Time frame: 10 years

    the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.

Secondary outcomes

  1. Treatment With a Systemic Therapy

    Time frame: At diagnosis of metastatic disease

    Proportion of metastatic patients treated with a systemic therapy

  2. Proportion of Participants Included in a Clinical Trial

    Time frame: 5 years

    Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • French Sarcoma Group

Registry information

Official study title

Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (GIST) in a Real-life Setting: the METAGIST Observational Study

Acronym: METAGIST

Important dates

Study start
1990
Primary completion
2024
Study completion
2024
First posted
May 24, 2019
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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