Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03963544
Other study ID # IB2019-METAGIST
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1990
Est. completion date December 2024

Study information

Verified date December 2021
Source Institut Bergonié
Contact Carine A Bellera, PhD
Email c.bellera@bordeaux.unicancer.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France Institut Bergonié, Comprehensive Cancer Center Bordeaux

Sponsors (2)

Lead Sponsor Collaborator
Institut Bergonié French Sarcoma Group

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to next treatment (TNT) time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first. 2 years
Primary Overall survival (OS) the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death. 2 years
See also
  Status Clinical Trial Phase
Completed NCT01506336 - Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib Phase 2