Actively Recruiting
Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)
Led by Centre Leon Berard · Updated on 2023-09-01
50
Participants Needed
13
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Histologically confirmed diagnosis of advanced or metastatic GIST with c-kit (CD117) expression
- ECOG performance status from 0 to 2 within 7 days before inclusion
- Receiving imatinib treatment (300 or 400 mg/day) continuously for at least 10 years with limited interruptions
- Disease controlled without progression while on imatinib
- Willing and able to follow study visits, treatments, lab tests, and procedures
- Covered by medical or health insurance
- Signed informed consent after being informed about the study
You will not qualify if you...
- Using other approved or investigational anticancer drugs concurrently
- GIST with PDGFRA D842V mutation
- Major concurrent diseases affecting heart, liver, kidneys, blood system, or other serious conditions interfering with study
- History of other cancers within past 3 years except certain skin or cervical cancers
- Receiving warfarin or prohibited medications concurrently (low-molecular weight heparin allowed)
- Known HIV infection
- Major surgery within 2 weeks before study entry
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant or breastfeeding women
- Patients requiring legal guardianship or deprived of liberty
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CHU Besançon
Besançon, France, 25000
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
3
CHU Dupuytren
Limoges, France, 87042
Actively Recruiting
4
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
5
Institut Paoli Calmettes
Marseille, France, 13273
Not Yet Recruiting
6
Institut Curie
Paris, France, 75005
Not Yet Recruiting
7
CHU de Reims
Reims, France, 51100
Actively Recruiting
8
Centre Eugène Marquis
Rennes, France, 35042
Not Yet Recruiting
9
Institut de Cancérologie de l'Ouest - Site Réné Gauducheau
Saint-Herblain, France, 44805
Not Yet Recruiting
10
Institut de Cancérologie Lucien NEUWIRTH
Saint-Paul-en-Jarez, France, 42270
Not Yet Recruiting
11
Institut Claudius Regaud
Toulouse, France, 31059
Not Yet Recruiting
12
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Not Yet Recruiting
13
Institut Goustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
J
Jean-Yves BLAY, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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