Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Imatinib Mesylate

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

masitinib

sunitinib

Axel Le Cesne, MD

The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks

From date of randomization until the date of death from any cause, assessed up to 36 weeks

AB Science

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

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

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

Carine A Bellera, PhD

Simone Mathoulin-Pélissier, MD/PhD

Maud Toulmonde, MD

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

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

time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.

the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.

French Sarcoma Group

Institut Bergonié

This cohort include patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.

This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments

Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)

Giovanni Grignani

This is a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

In the field of soft tissue sarcomas, Gastrointestinal Stromal Tumors (GIST) represents a really peculiar neoplasm for its biological and clinical properties. Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological adjuvant treatment is reserved to those with a relevant risk of recurrence/progression.

After tumor removal, clinical and radiological follow-up is of central importance to early intercept recurrence and to evaluate the most correct subsequent therapeutic approach. In particular, for the group of patients with GIST at very-low and low risk of recurrence/progression, the evidences to support a specific follow-up program and its features are poor.

On the basis of the aforementioned considerations, we propose a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.

The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020

Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes

Collection of retrospectively imaging characteristics

Collection of retrospectively imaging characteristics.

Onset of other neoplasm will be recoreded

Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis

Time elapsed form the treatment (any) start and the onset of recurrence

Time elapsed form the onset of 1st progression to a further progression

Time elapsed for the diagnosis to the death of disease

Time elapsed for the diagnosis to the death for any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib	NCT01506336	Gastro Intestin...	masitinib sunitinib	18 Years -	AB Science
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib	NCT01506336	Gastro Intestin...	masitinib sunitinib	18 Years -	AB Science
Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (METAGIST)	NCT03963544	Gastro Intestin...	oral tyrosine-k...	18 Years -	Institut Bergonié
Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)	NCT04599660	GIST	Treatment of Lo...	19 Years -	Italian Sarcoma Group
Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (METAGIST)	NCT03963544	Gastro Intestin...	oral tyrosine-k...	18 Years -	Institut Bergonié

Spots Global Cancer Trial Database for gastro intestinal stromal tumor