Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index

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Brief Title

Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index

Official Title

Efficacy of Adjuvant Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index. Multicenter, Prospective, Randomized Study. Etude Multicentrique, Prospective, randomisée

Brief Summary

      Following the ACOSOG Z9001trial, imatinib received market authorization in Europe for
      patients with GIST at significant risk of relapse in the adjuvant setting, according to the
      classifications of Miettinen and Joensuu. Thereafter, the SSG XVIII / AI trial proved the
      need to revise the recommendations of the European Society for Medical Oncology regarding the
      optimal duration of treatment, which is currently three years. Patients at low risk of
      recurrence should not receive adjuvant treatment with imatinib and recommendations cannot be
      made from the literature data as to the indication of adjuvant treatment for patients with an
      intermediate risk of relapse. The provision of prognostic molecular markers in this group of
      so-called intermediate-risk subjects would facilitate the identification of responders to
      imatinib and avoid overtreating some patients and undertreating others who would benefit from
      Imatinib. Recently, Lagarde et al. have shown that the Genomic Index (GI = A ² / C, where A
      is the total number of alterations gains or losses and C is the number of chromosomes
      involved in these alterations in Comparative Genomic Hybridization array(CGH array)) could
      have prognostic value in GIST, particularly in intermediate risk GISTs. More recent work by
      the same author in 100 cases of GISTs with intermediate prognosis according to the
      classification of Miettinem identified two prognostic groups based on GI. The rate of
      metastatic relapse at 2 years was 30.6% in the group with GI greater than 10 versus 5.4% in
      the group with GI less than 10 (manuscript under preparation). Thus, it is legitimate to set
      up a randomized trial to study the effectiveness of adjuvant treatment with imatinib in the
      GIST population at intermediate risk of relapse and with a high GI. This study is a
      prospective randomized clinical trial: a phase III, open-label, 2 parallel groups,
      multicenter study. The primary objective of this study is to assess the efficacy of adjuvant
      Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk
      gastrointestinal stromal tumor presenting a high Genomic Grade Index. The second objectives
      of this study are to compare the two therapeutic approaches in terms of metastasis-free
      survival at 1 year, 2 years and 3 years, overall survival, clinical and biological tolerance,
      safety and Quality of life of patients and caregivers. The eligible subjects must meet all of
      the following criteria : subject with a gastrointestinal stromal tumor, intermediary risk
      from the Armed Forces Institute of Pathology classification [Miettenen 2006], subject with
      Genomic Grade Index higher than 10 determined by CGH array, subject with surgery for primary
      tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate, subject
      with no evidence of residual macroscopic disease after surgery and with a medical decision to
      prescribe imatinib. Subjects meeting any of the following criteria must not be enrolled :
      subject who have experienced spontaneous tumor rupture before surgery, subject whose tumor
      has a PDGFRA D842V mutation evidenced by sequencing from tumor Block and subject whose
      mutational status meets the wild phenotype definition as evidenced by sequencing from tumor
      Block.

      The Standard Group will receive adjuvant imatinib at a dose of 400 mg per day for a period of
      3 years. Patients will be assessed for metastases every three months for three years with
      thoraco-abdominal and pelvic CT scan. The Experimental Group will receive the same
      thoraco-abdominal and pelvic CT scan. The estimated proportion of subjects relapsing at 2
      years will be 30% in the experimental group and 2.5% in the standard group: alpha risk, 5%,
      power 80%. A total of 80 subjects (40 in each arm) will be included. This is a trial
      combining two learned societies that already are taking part in many clinical trials in
      France (French Sarcoma Group and French Digestive Cancer Federation). The expected benefits
      for patients are : not treat subjects for whom this treatment would offer too little benefit
      weighed against the disadvantages and treat subjects in whom this treatment would provide a
      real benefit and reduce the cost of treatment in patients who would not benefit from being
      treated by imatinib. The originality of this study is that it will include molecular data in
      the therapeutic decision and demonstrate the concept of individualized treatment in this
      patient population. This could ultimately change the current recommendations.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Rate of metastatic relapse in GIST patient

Secondary Outcome

 Overall survival

Condition

Gastrointestinal Stromal Tumor

Intervention

Imatinib

Study Arms / Comparison Groups

 Standard Group
Description:  The Standard Group will receive adjuvant imatinib at a dose of 400 mg per day for a period of 3 years. Patients will be assessed for metastases every three months for three years with thoraco-abdominal and pelvic CT scan.

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

80

Start Date

October 2015

Completion Date

October 2020

Primary Completion Date

October 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Man or woman 18 years old or over and PS:0-2

          -  No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological
             therapy

          -  Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces
             Institute of Pathology classification [Miettenen 2006]

          -  Subject with Genomic Grade Index higher than 10 determined by CGH array;

          -  Subject with surgery for primary tumor performed from 2 weeks to 2 months before
             starting adjuvant Imatinib mesylate;

          -  Subject with no evidence of residual macroscopic disease after surgery (RO).
             Microscopically infiltrated margins, or supposed to be are allowed (R1)

          -  Subjects with absence of distant metastases

          -  Subject with a medical decision of treatment with its in accordance with imatinib
             marketed authorization.

        Exclusion Criteria:

          -  Minors or pregnant or breast-feeding women.

          -  Subject with a contraindication to Imatinib, a known hypersensitivity to the active
             substance or to any of the excipients (ambivalence clause);

          -  Subject treated with medicinal products that induce CYP3A4;

          -  Subject who have experienced spontaneous tumor rupture before surgery (risk of
             spread);

          -  Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor
             block;

          -  Subject whose mutational status meets the wild phenotype definition as evidenced by
             sequencing from tumor block
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Urielle DESALBRES, +33491384408, [email protected]



Administrative Informations


NCT ID

NCT02576080

Organization ID

2014-31

Secondary IDs

2014-005255-87

Responsible Party

Sponsor

Study Sponsor

Assistance Publique Hopitaux De Marseille


Study Sponsor

Urielle DESALBRES, Study Director, Assistance Publique Hopitaux De Marseille


Verification Date

October 2015