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

Recruiting

• Conditions: Gastro Intestinal Stromal Tumor

• Registration Number: NCT03963544
• Lead Sponsor: Institut Bergonié

Brief Summary

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 impact of each treatment line on patients outcome in terms of time to next treatment (TNT) and survival

Detailed Description

Not available

Study Timeline

• Study Start: 1990-01
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-24
• Status Verified: 2021-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to next treatment (TNT)	2 years	time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
Overall survival (OS)	2 years	the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.

Trial Locations

Locations (1)

Institut Bergonié, Comprehensive Cancer Center; 🇫🇷 Bordeaux, France