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| Name | Class |
|---|---|
| French Sarcoma Group | OTHER |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations | Drug | oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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metastatic Gastrointestinal Stromal Tumor
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| Name | Affiliation | Role |
|---|---|---|
| Maud Toulmonde, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié, Comprehensive Cancer Center | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37686582 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Participants with metastatic Gastrointestinal stromal tumors (GIST) treated in one of the three national coordinating centers from NETSARC (Institut Bergonié, Centre Léon Berard and Institut Gustave Roussy) from 1990 to 2018. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Participants with metastatic Gastrointestinal stromal tumors (GIST) treated in one of the three national coordinating centers from NETSARC (Institut Bergonié, Centre Léon Berard and Institut Gustave Roussy) from 1990 to 2018. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who received systemic treatment | Posted | Median | 95% Confidence Interval | months | 10 years |
|
|
10 years Adverse events (serious and non-serious) were not collected
Adverse events (serious and non-serious) were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Metastatic Gastrointestinal Stromal Tumors (GIST) | Participants with metastatic Gastrointestinal stromal tumors (GIST) treated in one of the three national coordinating centers from NETSARC (Institut Bergonié, Centre Léon Berard and Institut Gustave Roussy) from 1990 to 2018. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trial Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2018 | Sep 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease
| 5 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Overall Survival (OS) Time | the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death. | Posted | Median | 95% Confidence Interval | months | 10 years |
|
|
|
| Secondary | Treatment With a Systemic Therapy | Proportion of metastatic patients treated with a systemic therapy | Posted | Count of Participants | Participants | At diagnosis of metastatic disease |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 221 |
| 492 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D020164 | Chemical Actions and Uses |