Clinical Trials Directory

Trials / Completed

CompletedNCT03963544

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
492 (actual)
Sponsor
Institut Bergonié · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Interventions

TypeNameDescription
DRUGoral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendationsoral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR

Timeline

Start date
1990-01-01
Primary completion
2024-09-01
Completion
2024-12-01
First posted
2019-05-24
Last updated
2025-12-10
Results posted
2025-12-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03963544. Inclusion in this directory is not an endorsement.