Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced/Metastatic Gastrointestinal Stromal Tumors (GISTs)
Sponsor study identifier
interventional
50
1 country
13
Study Start
January 3, 2022
Actual (reported)Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST. In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease. In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2021
Actual (reported)August 18, 2021
Actual (reported)January 3, 2022
Actual (reported)January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progression-free-rate at 6 months (PFR 6m)
Defined as the rate of patients with a non-progressive disease 6 months after randomization
6 months after randomization
Progression-free-survival (PFS)
5 years (i.e. at the the time of last patient last visit)
Overall Survival (OS)
5 years (i.e. at the the time of last patient last visit)
Immediate interruption of imatinib until progressive disease. In case of 1st relapse, imatinib will be reintroduced at 400mg/d and further increased at 800mg/d in case of 2nd relapse after re-introduction.
Maintenance of imatinib at the last dose routinely taken by the patient in the 10-year period prior to randomization (either 300 or 400 mg once daily). In case of progressive disease imatinib will be increased up to 800mg/day.
Imatinib interruption
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU Besançon
Besançon, 25000, France
Institut Bergonié
Bordeaux, 33076, France
Jean-Yves BLAY, Pr
Centre Léon Bérard, Lyon
First Submitted
August 2, 2021
First Posted
August 18, 2021
Study Start
January 3, 2022
Actual (reported)Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety profile
5 years (i.e. at the the time of last patient last visit)
Quality of Life (QoL)
5 years (i.e. at the the time of last patient last visit)
Progression-free survival rechallenge
5 years (i.e. at the the time of last patient last visit)
Contact the study team to confirm eligibility.
CHU Dupuytren
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13273, France
Institut Curie
Paris, 75005, France
CHU de Reims
Reims, 51100, France
Centre Eugène Marquis
Rennes, 35042, France
Institut de Cancérologie de l'Ouest - Site Réné Gauducheau
Saint-Herblain, 44805, France
Institut de Cancérologie Lucien NEUWIRTH
Saint-Paul-en-Jarez, 42270, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Institut Goustave Roussy
Villejuif, 94805, France
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 1, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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