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

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Observational Registry Data on GIST Patients DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) Unifying Advanced Treatment With Advanced Imaging Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor Sarcopenia in Patients With Gastrointestinal Stromal Tumours Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Symptom Inventory for Gastrointestinal Stromal Tumors A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST) A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors Gastrointestinal Stromal Tumors (GIST) Registry Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study 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Brief Title

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

Official Title

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)

Brief Summary

      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.
    

Detailed Description

      Gastrointestinal stromal tumors (GISTs) arise from mesenchymal stem cells which also give
      rise to the interstitial cells of Cajal within the GI tract. A large majority of GIST tumors
      harbour activating mutations in the proto-oncogenes KIT and/or PDGFRA, both coding
      cell-surface cytokine receptors with tyrosine-protein kinase activity.

      Imatinib mesilate (Glivec®, Novartis Pharma SAS) is a selective tyrosine kinase inhibitor,
      leading to inhibition of KIT and PDGFRA signalling pathways. The introduction of imatinib has
      revolutionised the therapeutic management of GIST patients and has provided an unprecedented
      demonstration of the clinical benefit of a targeted therapy for patients with
      advanced/metastatic solid tumors.

      Several studies have investigated the optimal duration of imatinib treatment in the advanced
      phase. The BFR14 trial demonstrated that 31% of advanced GIST patients treated with
      continuous imatinib beyond 1 year had documented disease progression compared to 81% in the
      interrupted imatinib group (p<0.0001). The authors concluded that treatment interruption
      resulted in rapid progression in most patients with advanced GIST and therefore should not be
      recommended in standard practice unless the patient experienced significant toxicity or
      disease progression. An update of the BFR14 trial at a median follow-up of 37 months showed
      that 91% of patients in the interrupted arm versus 62% in the continuous arm experienced
      progressive disease (p<0.0001). Majority (92%) of patients in the interrupted arm achieved
      tumor control once they recommenced imatinib after first progression. Ray-Coquard et al.
      reported that stopping imatinib after 5 years resulted in a higher rate of disease
      progression than imatinib maintenance in patients with advanced GIST responding to or
      stabilised by imatinib.

      However, whether lifelong imatinib treatment duration is mandatory in metastatic GIST
      patients remains unclear. It is not known whether a cytostatic treatment of 10 years or
      longer is sufficient to inhibit definitively GIST cancer cells proliferation even after the
      interruption of the kinase inhibitor. This question has broad implications for all targeted
      therapies.

      The aim of the present study is to address this question rigorously in a randomized setting.
      The investigators therefore want to determine whether prolonged use of imatinib beyond 10
      years is needed to reduce the risk of GIST recurrence and to improve overall survival. For
      patients with imatinib interruption after at least 10 years of treatment, the investigators
      want to determine if imatinib rechallenge is efficient for treating recurrence. Therefore,
      the investigators design an open-label, randomized, multicenter phase II study to determine
      the clinical impact of maintaining imatinib treatment beyond 10 years in patients with
      locally advanced/metastatic GIST.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free-rate at 6 months (PFR 6m)

Secondary Outcome

 Progression-free-survival (PFS)

Condition

Metastatic Gastrointestinal Stromal Tumor (GIST)

Intervention

Imatinib tablets

Study Arms / Comparison Groups

 Imatinib interruption
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

October 2021

Completion Date

October 2024

Primary Completion Date

April 2022

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Yves BLAY, Pr, +33 4 78 78 27 57, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05009927

Organization ID

GIST-TEN


Responsible Party

Sponsor

Study Sponsor

Centre Leon Berard


Study Sponsor

Jean-Yves BLAY, Pr, Principal Investigator, Centre Léon Bérard, Lyon


Verification Date

August 2021