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Recruiting nowPhase 2Ages 18 Years and up

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

Sponsor: Centre Leon Berard · NCT05009927 on ClinicalTrials.gov ↗

Conditions studied

Metastatic Gastrointestinal Stromal Tumor (GIST)C-KIT MutationAdvanced Gastrointestinal Stromal Tumor (GIST)

What it tests

  • Imatinib tabletsdrug

Where it's running13 sites

13 international sites
  • CHU Besançon

    Besançon, France 25000

    Recruiting now
    • Elsa KALBACHER, MD(contact)03.70.63.24.03[email protected]
    • Elsa KALBACHER, MD(principal investigator)
    • Loïc CHAIGNEAU, MD(sub investigator)
    • Guillaume MEYNARD, MD(sub investigator)
  • Institut Bergonié

    Bordeaux, France 33076

    Recruiting now
    • Antoine ITALIANO(contact)[email protected]
    • Antoine ITALIANO(principal investigator)
    • Maud TOULMONDE(sub investigator)
    • Kevin BOURCIER(sub investigator)
    • Sophie COUSIN(sub investigator)
  • CHU Dupuytren

    Limoges, France 87042

    Recruiting now
  • Centre Léon Bérard

    Lyon, France 69373

    Recruiting now
    • Jean-Yves BLAY, PhD(contact)
    • (contact)04 78 78 27 57[email protected]
    • Jean-Yves BLAY, PhD(principal investigator)
    • Mehdi BRAHMI(sub investigator)
    • Armelle DUFRESNE(sub investigator)
    • Isabelle RAY-COQUARD(sub investigator)
  • Institut Paoli Calmettes

    Marseille, France 13273

    Opening soon
    • François BERTUCCI, PhD(contact)[email protected]
    • François BERTUCCI, PhD(principal investigator)
    • Audrey MONNEUR(sub investigator)
    • Elika LOIR(sub investigator)
    • Simon LAUNAY(sub investigator)
    • Frédéric VIRET(sub investigator)
    • Brice CHANEZ(sub investigator)
    • Delphine LOUVEL PERROT(sub investigator)
  • Institut Curie

    Paris, France 75005

    Opening soon
    • Sophie PIPERNO NEUMANN(contact)[email protected]
    • Sophie PIPERNO NEUMANN(principal investigator)
  • CHU de Reims

    Reims, France 51100

    Recruiting now
    • Olivier BOUCHE, PhD(contact)
    • Olivier BOUCHE, PhD(principal investigator)
    • Mathilde BRASSEUR, MD(sub investigator)
    • Damien BOTSEN, MD(sub investigator)
  • Centre Eugène Marquis

    Rennes, France 35042

    Opening soon
    • Christophe PERRIN, MD(sub investigator)
    • Marc PRACHT, MD(principal investigator)
    • Angélique BRUNOT, MD(sub investigator)
    • Astrid LIEVRE, PhD(sub investigator)
    • Eugénie RIGAULT, MD(sub investigator)
    • Thomas GRAINVILLE, MD(sub investigator)
    • Anne-Sophie MOUSSADDAQ, MD(sub investigator)
  • Institut de Cancérologie de l'Ouest - Site Réné Gauducheau

    Saint-Herblain, France 44805

    Opening soon
    • Emanuelle BOMPAS(contact)
    • Emanuelle BOMPAS(principal investigator)
    • Fréderic ROLLAND(sub investigator)
    • Damien VANSTEENE(sub investigator)
  • Institut de Cancérologie Lucien NEUWIRTH

    Saint-Paul-en-Jarez, France 42270

    Opening soon
    • Olivier COLLARD, MD(contact)[email protected]
    • Olivier COLLARD, MD(principal investigator)
    • Cécile VASSAL, MD(sub investigator)
  • Institut Claudius Regaud

    Toulouse, France 31059

    Opening soon
    • Valentin THIBAUD(contact)[email protected]
    • Valentin THIBAUD(principal investigator)
    • Iphigénie KORAKIS(sub investigator)
    • Christine CHEVREAU(sub investigator)
  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, France 54519

    Opening soon
    • Maria RIOS, MD(contact)
    • Maria RIOS, MD(principal investigator)
  • Institut Goustave Roussy

    Villejuif, France 94805

    Recruiting now
    • Axel LE CESNE, PhD(contact)01 42 11 43 16[email protected]
    • Axel LE CESNE, PhD(principal investigator)
    • Rastislav BAHLEDA, MD(sub investigator)
    • Olivier MIR, MD(sub investigator)
    • Benjamin VERRET, MD(sub investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* Patients ≥18 years of age;
* Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
* Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.
* Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
* Patient with controlled disease (without any progression under imatinib);
* Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;
* Covered by a medical/health insurance;
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

* Patient concurrently using other approved or investigational antineoplastic agents;
* Patient with GIST harboring the mutation D842V in PDGFRA;
* Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
* Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;
* Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
* Major surgery within 2 weeks prior to study entry.
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Pregnant or breastfeeding woman
* Patient requiring tutorship or curatorship or patient deprivied of liberty.

Updated 2023-09-01 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.