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    Summary
    EudraCT Number:2011-005838-19
    Sponsor's Protocol Code Number:2011.697
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-21
    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 number2011-005838-19
    A.3Full title of the trial
    MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF THE RESECTION OF GLIOBLASTOMAS - THE RESECT STUDY
    EVALUATION MEDICO-ECONOMIQUE DE LA CHIRURGIE GUIDEE PAR FLUORESCENCE POUR L'OPTIMISATION DE LA RESECTION DES GLIOBLASTOMES – ETUDE RESECT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF THE RESECTION OF GLIOBLASTOMAS - THE RESECT STUDY
    EVALUATION MEDICO-ECONOMIQUE DE LA CHIRURGIE GUIDEE PAR FLUORESCENCE POUR L'OPTIMISATION DE LA RESECTION DES GLIOBLASTOMES – ETUDE RESECT
    A.3.2Name or abbreviated title of the trial where available
    RESECT
    A.4.1Sponsor's protocol code number2011.697
    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 SponsorHospics Civils de Lyon
    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 supportMinistère de la santé, INCA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPICES CIVILS DE LYON
    B.5.2Functional name of contact pointZUBLENA
    B.5.3 Address:
    B.5.3.1Street Address3 QUAI DES CELESTINS
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number04 72 11 54 11
    B.5.5Fax number04 72 11 51 90
    B.5.6E-mailirene.zublena@chu-lyon.fr
    D. IMP Identification
    D.IMP: 1
    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 GLIOLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMEDAC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma
    Glioblastome
    E.1.1.1Medical condition in easily understood language
    Brain tumor
    Tumeur cérébrale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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
    Percentage of patients with complete surgical excision of the brain tumor
    Pourcentage de patients dont l’exérèse chirurgicale de la tumeur est complète, objectivée par l’absence de reliquat tumoral sur l’IRM post-opératoire précoce (avant 48 heures) par un comité central indépendant de lecture avec analyse qualitative de la prise de contraste sur une console de relecture à usage diagnostique
    E.2.2Secondary objectives of the trial
    - Diagnostic value of the two intraoperative techniques
    - Quantification of residual tumor (contrast enhancement) on MRI
    - Rate of recurrence-free survival at 6 months,
    - Rate of overall survival at 24 months,
    - Rate of overall survival at 60 months,
    - Evaluation of the quality of life every 3 months
    - Evaluation of early morbidity at 8 days and 3 months
    - Duration of the surgical procedure according to the technique used.
    - Calculation of cost-effectiveness ratio difference between the two strategies.
    - Valeur diagnostique des deux techniques per-opératoires
    - Quantification du reliquat tumoral sur l’IRM post-opératoire précoce (avant 48 heures)
    -Taux de survie sans récidive à 6 mois
    - Taux de survie globale à 24 mois
    - Taux de survie globale à 60 mois
    - Evaluation de la qualité de vie tous les 3 mois
    - Evaluation de la morbidité précoce à 8 jours et de la morbidité tardive à 3 mois
    - Durée de la procédure chirurgicale selon la technique employée.
    - Calcul du ratio coût-efficacité différentiel entre les deux stratégies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF THE RESECTION OF GLIOBLASTOMAS - An Ancillary, observational, prospective, non-interventional, multicentric study from RESECT study,
    EVALUATION MEDICO-ECONOMIQUE DE LA CHIRURGIE GUIDEE PAR FLUORESCENCE POUR L'OPTIMISATION DE LA RESECTION DES GLIOBLASTOMES – ETUDE ANCILLAIRE, MULTICENTRIQUE, OBSERVATIONNELLE, PROSPECTIVE, NON INTERVENTIONNELLE AU PROTOCOLE RESECT
    E.3Principal inclusion criteria
    Pre inclusion criteria :
    -Age greater than 18 years.
    -Maggiore unprotected.
    -Patient-affiliated to a National Health Insurance.
    -Patient with intracerebral tumor, supra-tentorial hemispheric newly diagnosed and untreated previously, the MRI features suggestive of a glioblastoma.
    -Indication to surgical treatment by excision.
    -Against-No medical indication for surgery, ASA score less than 4.
    -Patient eligible for further treatment with radiotherapy and concurrent chemotherapy and adjuvant chemotherapy according to the scheme proposed by Stupp. (1) For patients older than 70 years, Stupp protocol, radiotherapy alone or chemotherapy will be administered according to the recommendations of each center after reviewing the file in RCP
    -Negative pregnancy test for women of childbearing age

    Inclusion criteria :
    -Tumor location accessible to excision as complete as possible validated by pre operative evaluation by a committee of surgery outside the center inclusion (majority opinion favorable surgical taken on 3 reviews)
    Critères de pré inclusion:
    -Age supérieur à 18 ans.
    -Majeur non protégé.
    -Patient affilié à un régime de l’Assurance Maladie.
    -Patient présentant une tumeur intra-cérébrale, supra-tentorielle et hémisphérique nouvellement diagnostiquée et non traitée au préalable, dont les caractéristiques IRM sont évocatrices d’un glioblastome.
    -Indication à un traitement chirurgical par exérèse.
    -Absence de contre-indication d’ordre médical à la chirurgie, score ASA inférieur à 4.
    -Patient éligible à un traitement complémentaire par radiothérapie et chimiothérapie concomitante puis chimiothérapie adjuvante selon le schéma proposé par STUPP.(1) Pour les patients de plus de 70 ans, un protocole STUPP, une radiothérapie isolée ou une chimiothérapie seront administrées selon les recommandations de chaque centre après étude du dossier en RCP
    -Test de grossesse négatif pour les femmes en âge de procréer.

    Critères d'inclusion :
    Localisation tumorale accessible à une exérèse la plus complète possible validée en pre opératoire par un comité d’évaluation de chirurgiens extérieurs au centre d’inclusion (avis majoritaire favorable pris sur 3 avis chirurgicaux)
    E.4Principal exclusion criteria
    Non inclusion criteria :
    -Contraindications to performing an MRI (pacemaker).
    -hypersensitivity to 5-ALA or porphyrins,
    -Hypersensitivity to parahydroxybenzoate of méthyle or propyl
    - Renal lithiasis oxalate-calcium
    - Glioblastoma-known and previously treated with surgery, radiotherapy and / or chemotherapy.
    -History of cancer.
    -Location tumor in the brainstem, the midline, basal ganglia or posterior cranial fossa.
    -Patient with cons-indication to the achievement of further processing. (1)
    -Patient with porphyria, renal failure (creatinine> 177 μmolL), liver (gamma glutamyl transpeptidase> 100 U / L, prothrombin time <60%, bilirubin> 51μmol / L).
    -Patient refused to sign a consent form.
    -Participation in the course of the patient to another trial.
    Critère de non inclusion :
    -Contre-indication à la réalisation d’une IRM (pace-maker).
    -hypersensibilité connue au 5-ALA ou aux porphyrines,
    -Hypersensibilité au parahydroxybenzoate de méthyle ou de propyle
    -Lithiases rénales oxalo-calciques
    -Glioblastome connu et préalablement traitée par chirurgie, radiothérapie et/ou chimiothérapie.
    -Antécédent de cancer.
    -Localisation tumorale dans le tronc cérébral, la ligne médiane, les noyaux gris centraux ou la fosse crânienne postérieure.
    -Patient présentant une contre-indication à la réalisation d’un traitement complémentaire.(1)
    -Patient présentant une porphyrie, une insuffisance rénale (créatinine >177 µmolL), hépatique (gamma glutamyl transpeptidase > 100 U/L, taux de prothrombine <60%, bilirubine > 51µmol/L).
    -Patient refusant de signer un formulaire de consentement éclairé.
    -Participation en cours du patient à un autre essai clinique.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with surgical resection of the tumor is complete, objectified by the absence of residual tumor on MRI early postoperative (within 48 hours) by the neurosurgeon who performed the surgical procedure and the neuro-radiologist who MRI performed with qualitative analysis of contrast enhancement during the initial clinical analysis. This double reading (Independent Committee and neurosurgeon and neuroradiologist at each center) will assess the reliability of interpretations of postoperative imaging.
    Pourcentage de patients dont l’exérèse chirurgicale de la tumeur est complète, objectivée par l’absence de reliquat tumoral sur l’IRM post-opératoire précoce (avant 48 heures) par un comité central indépendant de lecture avec analyse qualitative de la prise de contraste sur une console de relecture à usage diagnostique
    E.5.1.1Timepoint(s) of evaluation of this end point
    two days
    48 heures
    E.5.2Secondary end point(s)
    Clinic :
    1-Quantification of relict tumor by an independent expert committee.
    2-Values ​​of the diagnostic quality of resection of both techniques intraoperative evaluated by calculating the sensitivity, specificity, positive predictive value and negative, the gold standard is defined by the presence or absence of tumor tissue and / or tumor infiltration of the samples performed on the banks of resection (limits anterior, posterior, external, internal, deep anterior and posterior deep) and performed in the usual manner after surgery.
    3-Rate of recurrence-free survival at 6 months, recurrence is defined by the appearance of a new tumor lesion with minimal volume is set to 0.175 cm3 by increasing the volume of residual tumor 25% or more by need to increase the steroids
    4-Rate of overall survival at 24 months, measured from the number of patients who died whatever the cause
    5-Rate of overall survival at 60 months, estimated from the number of patients dying whatever the cause
    6-Evaluation of quality of life before resection and at 3, 6, 9, 12, 15, 18 and 24 months after surgical excision using the questionnaire EORTC QLQ-C30 with the module BN20, specific brain tumors
    7-Evaluation of early morbidity in 8 days and 3 months late morbidity
    8-Duration of the surgical procedure according to the technique used.

    Economic :
    compare the two dimensions of efficacy outcomes and costs of both strategies supported glioblastomas
    Clinique :
    -Quantification du relicat tumoral par le comité d’expert indépendant. L’analyse du volume sera faite par segmentation sur l’IRM post-opératoire et l’IRM pré-opératoire.
    -Valeurs diagnostiques de la qualité de l’exérèse des deux techniques per-opératoires évaluée par le calcul de la sensibilité, spécificité, valeur prédictive positive et négative, le gold standard étant défini par l’existence ou non de tissu tumoral et/ou d’infiltration tumorale sur les prélèvements effectuées sur les berges de résection (limites antérieure, postérieure, externe, interne, profonde antérieure et profonde postérieure) et réalisées de façon habituelle en fin d’intervention.
    -Taux de survie sans récidive à 6 mois, la récidive étant définie par l’apparition d’une nouvelle lésion tumorale dont le volume minimal sera défini à 0,175 cm3, par l’augmentation du volume tumoral résiduel de plus de 25% ou par la nécessité d’augmenter la corticothérapie.(1, 21) Le délai de survie sans récidive sera défini comme le délai entre la date d’exérèse et la date de diagnostic de la progression tumorale ou la date de dernière nouvelle ou la date de point. Le taux de survie sans récidive à 6 mois sera analysé selon la stratégie chirurgicale utilisée, selon le caractère complet ou incomplet de la résection et selon les centres.
    -Taux de survie globale à 24 mois, évaluée à partir du nombre de patients décédés quelle qu’en soit la cause. Le délai de survie globale sera défini comme le temps entre la date d’exérèse et la date de décès, toutes causes confondues ou la date de dernière nouvelle ou la date de point. Le taux de survie globale à 24 mois sera analysé selon la stratégie chirurgicale utilisée, selon le caractère complet ou incomplet de la résection et selon les centres
    -Taux de survie globale à 60 mois, évaluée à partir du nombre de patients décédés quelle qu’en soit la cause. Le délai de survie globale sera défini comme le temps entre la date d’exérèse et la date de décès, toutes causes confondues ou la date de dernière nouvelle ou la date de point.
    -Evaluation de la qualité de vie avant l’exérèse puis à 3, 6, 9, 12, 15, 18 et 24 mois après l’exérèse chirurgicale à l’aide du questionnaire de l’EORTC QLQ-C30 avec le module BN20, spécifique des tumeurs cérébrales
    -Evaluation de la morbidité précoce à 8 jours et de la morbidité tardive à 3 mois (déficit neurologique, infection du site opératoire, épilepsie secondaire, score de Karnofsky, Performance Status de l’OMS).
    -Durée de la procédure chirurgicale selon la technique employée.

    Economique :
    comparer sur la double dimension des résultats d’efficacité et des coûts les deux stratégies de prise en charge des glioblastomes
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    medico-economical
    Médico-économique
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned17
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    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 No
    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 state204
    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 Decision2012-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-06
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