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

NCT03963544 | Completed Results

• 1 other identifier: IB2019-METAGIST
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

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 patients outcome in terms of time to next treatment (TNT) and survival

Conditions

Gastro Intestinal Stromal Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Treatment With a Systemic Therapy

  At diagnosis of metastatic disease

• Proportion of Participants Included in a Clinical Trial

  5 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic Gastrointestinal Stromal Tumor

You may qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead
• French Sarcoma Group: collaborator

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 37686582 BACKGROUND

MeSH Terms

Interventions

Tyrosine Kinase Inhibitors

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Simone Mathoulin-Pélissier, Director of Clinical Trial Unit
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 5 56 33 33 33

Study Officials

• Maud Toulmonde, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 24, 2019
• Study Start: January 1, 1990
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Locations

FR (1)