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    Summary
    EudraCT Number:2018-000410-38
    Sponsor's Protocol Code Number:StrateGlio-1802
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-08-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-000410-38
    A.3Full title of the trial
    Phase III randomised trial evaluating treatment intensification with temozolomide in adults with a glioblastoma
    Essai de phase 3 évaluant le bénéfice d’une intensification du traitement par témozolomide (TMZ) pour les glioblastomes de l’adulte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III randomised trial evaluating chemotherapy treatment intensification with temozolomide in adults present with a glioblastoma
    Essai de phase 3 évaluant le bénéfice d’une intensification du traitement de chimiothérapie par témozolomide (TMZ) pour les patients présentant un glioblastome de l’adulte
    A.3.2Name or abbreviated title of the trial where available
    StrateGlio
    StrateGlio
    A.4.1Sponsor's protocol code numberStrateGlio-1802
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentre Oscar Lambret
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportpending funding
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Oscar Lambret
    B.5.2Functional name of contact pointSponsor Unit
    B.5.3 Address:
    B.5.3.1Street Address3 rue Frédéric Combemale
    B.5.3.2Town/ cityLille
    B.5.3.4CountryFrance
    B.5.6E-mailpromotion@o-lambret.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TEMODAL (TEMOZOLOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTEMOZOLOMIDE
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TEMODAL (TEMOZOLOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTEMOZOLOMIDE
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults with a de novo glioblastoma
    patients adultes présentant un glioblastome dit primaire
    E.1.1.1Medical condition in easily understood language
    Adults with a de novo glioblastoma i.e. without a medical history of glioma
    patients adultes présentant un glioblastome dit primaire c’est-à-dire sans antécédent de gliome.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of intensification with Temozolomide (early TMZ + prolonged adjuvant TMZ) compared to Stupp standard protocol, in terms of Overall Survival (OS)
    •Evaluer le bénéfice d’une intensification du traitement par temozolomide (TMZ) (prescription précoce et prolongation du traitement adjuvant) par rapport au protocole standard de Stupp en termes de survie globale (SG)
    E.2.2Secondary objectives of the trial
    Secondary objectives
    •To compare safety (hematological and non hematological adverse events) between both arms (intensified protocol vs standard protocol)
    •To evaluate the efficacy of intensification in terms of progression-free survival (PFS)
    •To evaluate the relative benefit/risk ratio using the Q-TWiST approach


    Exploratory objectives
    •To evaluate the feasibility of intensified treatment by comparing it to that of the standard treatment, in terms of doses received and dose-intensity.
    •To identify prognostic factors of OS and predictive factors of treatment response (clinical and biological factors, including MGMT methylation).
    •To describe the type of the progression (local or peri-local, remote in the brain, remote in the meninges)
    •To describe post-progression treatments.

    Secondaires :
    •Comparer la tolérance (effets indésirables hématologiques et extra-hématologiques) entre les 2 bras (protocole intensifié vs protocole standard)
    •Evaluer l’efficacité de l’intensification en termes de survie sans progression (SSP)
    •Evaluer le rapport bénéfice/ risque relatif en utilisant l’approche Q-TWiST


    Exploratoires :
    •Evaluer la faisabilité du traitement intensifié en la comparant à celle du traitement standard, en termes de doses reçues et de dose-intensité.
    •Identifier des facteurs pronostiques de SG des facteurs prédictifs de la réponse au traitement (facteurs cliniques et biologiques, dont la méthylation du promoteur du gène MGMT).
    •Décrire les modalités de la progression (locale ou péri-locale, à distance dans le cerveau, à distance dans les méninges)
    •Décrire les traitements post-progression

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient ≥18 years old
    -Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.
    -Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days)
    -Karnofsky performance status (KPS) ≥ 60%, or KPS <60% only related to glioma-related motor paresis.
    -Adequate biological functions: neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3 independent of transfusion, serum creatinine ≤ 1.5 times ULN; transaminases (ALAT/ ASAT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN (except in case of Gilbert’s disease)
    -Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)
    -Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.
    -Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
    -Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy
    -Written informed consent from patient or the person of trust (“personne de confiance”)
    -France and Belgium: Patient covered by the French or Belgian “Social Security” regime

    •Patient ≥18 ans
    •Diagnostic histologique de GBM de novo (diagnostic extemporané ou examen pathologique standard). En cas de diagnostic extemporané, le patient peut être inclus. Si le diagnostic n'est pas confirmé, le patient sera retiré de l'étude.
    •Délai entre la chirurgie/biopsie initiale et le début du traitement (pour le groupe expérimental) ≤ 15 jours (dans les 7 premiers jours si possible)
    •Karnofsky performance status (KPS) ≥ 60%, ou KPS < 60% uniquement lié à la parésie motrice associée au gliome.
    •Fonctions biologiques adéquates: neutrophiles ≥ 1500 / mm3, plaquettes ≥ 100 000 / mm3 indépendamment de transfusions, créatinine sérique ≤ 1,5 fois LSN; transaminases (ALAT / ASAT) ≤ 3 fois la LSN; bilirubine totale ≤ 1,5 fois la LSN (sauf en cas de maladie de Gilbert)
    •Critères généraux de toxicité (CTC): événements indésirables non hématologiques ≤ Grade 1 (sauf pour l'alopécie, les nausées, les vomissements et les symptômes neurologiques)
    •Les femmes en âge de procréer doivent réaliser un test de grossesse sérologique ou urinaire négatif dans les 7 jours précédant le début du traitement. Les patients sexuellement actifs doivent accepter d'utiliser une contraception adéquate et appropriée pendant le traitement et durant les 6 mois qui suivent l'arrêt du traitement.
    •Radiothérapie standard réalisable (60 Gy, 30 fractions)
    •Intervalle de temps inférieur à 43 jours entre la chirurgie/biopsie initiale et le début de la radiothérapie
    •Consentement éclairé du patient ou de la personne de confiance
    •France et Belgique: Patient couvert par le régime "Sécurité Sociale" française ou belge.
    E.4Principal exclusion criteria
    -Secondary or recurrent glioblastoma (GBM)
    -Planned use of tumor-treating electric fields
    -Planned use of Carmustine implants
    -Prior malignancy in the last 5 years before inclusion or concomitant
    -Severe myelosuppression
    -Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)
    -Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion).
    -Known current viral hepatitis, HIV infection or current active infectious disease
    -Inability to swallow oral medications or any mal-absorption condition
    -Pregnant or breastfeeding patients.
    -Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
    -Person under guardianship or curatorship
    •Glioblastome secondaire ou récurrent (GBM)
    •Utilisation prévue de champs électriques pour le traitement de la tumeur
    •Utilisation d'implants contenant de la carmustine
    •Antécédent d'autre cancer dans les 5 ans précédant l'inclusion
    •Myélosuppression sévère avant inclusion
    •Hypersensibilité connue à l'un des médicaments à l'étude, aux classes de médicaments à l'étude, aux excipients de la formulation ou à la dacarbazine (DTIC)
    •Traitement actuel ou récent avec un autre médicament expérimental ou patients inclus dans un essai clinique à visée thérapeutique (dans les 30 jours précédant l'inclusion).
    •Infection connue par les virus d'hépatite virale B ou C, par le VIH ou autre maladie infectieuse active
    •Patients incapables d'avaler ou d'absorber correctement les médicaments par voie orale
    •Femmes enceintes ou allaitantes.
    •Patients incapables d'être compliants à l'essai (raisons géographiques, sociales ou psychiques)
    •Patients sous tutelle ou curatelle
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news.
    Survie globale, définie comme le temps entre la date de randomisation et la date de décès quelle qu'en soit la cause. Les patients en vie seront censurés à la date des dernières nouvelles.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3,5 years after the beginning of the study
    3,5 ans après le début de l'étude
    E.5.2Secondary end point(s)
    Secondary endpoints
    •Adverse events occurring from randomization until disease progression will be reported and graded using the NCI-CTCAE v5.0 classification, including those related to the underlying disease or its progression. All AE will be analyzed, and described according to the reported causal relationship. An AE will be classified as Severe AE if grade is equal or higher than 3 for extra-hematological AE and grade 4 for hematological AE.
    •Progression-free survival will be defined as time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause. Patients alive without progressive disease will be censored at the date of last news.
    There will be no central radiological review. . The type of progression will be collected (local or peri-local, remotely in the brain, remotely in the meninges)
    •Q-TWiST: Quality-adjusted time without symptoms of disease or toxicity

    Exploratory endpoints
    •Treatment doses will be computed for each treatment component (radiotherapy and chemotherapy), and by treatment phase (early TMZ / concomitant TMZ / adjuvant TMZ). Early administration of TMZ is unlikely to result in leucopenia and / or thrombocytopenia, which could prevent or inhibit conventional concomitant standard dose chemoradiotherapy. It could also lead to platelet transfusions or infections. Patients will be notified. The percentage of deliveries of complete chemoradiotherapy treatment (TMZ and radiotherapy) will be compared in both arms.
    •Total dose of irradiation received and dose-intensity.
    •Predictive factors of overall survival: the list of studied factors will be defined later. The methylation of the MGMT promoter is mandatory and will be done in each center. Tumor material will be stored in order to study other biomarkers.
    •Description of the post-progression treatments: nature and duration.
    Secondaires
    •Tolérance : tous les événements indésirables (dont ceux reliés à la maladie ou à sa progression) survenant entre la date de randomisation et la date de première progression, seront recueillis et gradés selon l’échelle NCI-CTCAE v 5.0. Un évènement indésirable de grade ≥ 3 sera considéré comme « sévère ».
    •Survie sans progression, définie comme le temps entre la date de randomisation et la date de progression (critères RANO évalués par le centre investigateur, sans relecture centralisée) ou du décès quelle qu’en soit la cause. Les patients en vie sans progression sont censurés à la date des dernières nouvelles. Les modalités de la progression seront collectées (locale ou péri-locale, à distance dans le cerveau, à distance dans les méninges).
    •Q-TWiST: Temps sans progression et sans toxicité sévère.

    Paramètres exploratoires
    •Dose totale cumulée de témozolomide sur la durée complète du traitement (mg/m²) et dose-intensité en témozolomide (dose en mg/m²/semaine) sur la durée complète du traitement et dans les différentes phases du traitement (en distinguant : avant le début de la radiothérapie, en concomitant à la radiothérapie et après la radiothérapie)
    •Dose totale d’irradiation reçue et dose-intensité
    •Pour l’analyse exploratoire des facteurs pronostiques et prédictifs de la survie globale, la liste des facteurs étudiés sera définie ultérieurement. La méthylation du promoteur de la MGMT est obligatoire et sera faite dans chaque centre. Du matériel tumoral sera stocké afin de pouvoir étudier d’autres biomarqueurs.
    •Description des traitements post-progression : nature et durée

    E.5.2.1Timepoint(s) of evaluation of this end point
    3,5 years after the beginning of the study
    3,5 ans après le début de l'étude
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Le même médicament avec un schéma d'administration standard
    The same medicinal product with a standard administration scheme
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned43
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last visit of the last subject undergoing the trial. Forecast finish date (LPLV): Mars 2022
    The end of the trial is the last visit of the last subject undergoing the trial. : Fin prévisionnelle de la recherche (LPLV) : Mars 2022
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 535
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 134
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 535
    F.4.2.2In the whole clinical trial 535
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Aucun
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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