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

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

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

Study Overview

• Status: Completed
• Conditions: Gastro Intestinal Stromal Tumor
• Intervention / Treatment: Drug: oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations

• Study Type: Observational
• Enrollment (Actual): 492

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié, Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

metastatic Gastrointestinal Stromal Tumor

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Next Treatment (TNT)	time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.	10 years
Overall Survival (OS) Time	the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment With a Systemic Therapy	Proportion of metastatic patients treated with a systemic therapy	At diagnosis of metastatic disease
Proportion of Participants Included in a Clinical Trial	Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease	5 years

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Collaborators: French Sarcoma Group
• Investigators: Principal Investigator: Maud Toulmonde, MD, Institut Bergonie

Publications and helpful links

General Publications

• Toulmonde M, Dinart D, Brahmi M, Verret B, Jean-Denis M, Ducimetiere F, Desolneux G, Meeus P, Palussiere J, Buy X, Bouhamama A, Gillon P, Dufresne A, Henon C, Le Loarer F, Karanian M, Ngo C, Mathoulin-Pelissier S, Bellera C, Le Cesne A, Blay JY, Italiano A. Evolution of Patterns of Care and Outcomes in the Real-Life Setting for Patients with Metastatic GIST Treated in Three French Expert Centers over Three Decades. Cancers (Basel). 2023 Aug 28;15(17):4306. doi: 10.3390/cancers15174306.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1990
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Pharmacologic Actions; Chemical Actions and Uses; Tyrosine Kinase Inhibitors
• Other Study ID Numbers: IB2019-METAGIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No