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    The EU Clinical Trials Register currently displays   43872   clinical trials with a EudraCT protocol, of which   7291   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003806-18
    Sponsor's Protocol Code Number:IC2014-16
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-26
    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 number2015-003806-18
    A.3Full title of the trial
    IMPROVEMENT OF LOCAL CONTROL IN SKULL BASE AND SPINE CHORDOMAS TREATED BY SURGERY AND PROTONTHERAPY TARGETING HYPOXIC CELLS REVEALED BY POSITRON EMISSION TOMOGRAPHY NITROIMIDAZOLE ([18F]FAZA) PET/CT TRACERS.
    Amélioration du contrôle local dans les chordomes de la base du crâne, du rachis mobile et du sacrum traités par chirurgie et une protonthérapie de complément ciblée sur les cellules hypoxiques mises en évidence par TEP/TDM au [18-FLUOR] Fluoroazomycine-Arabinoside ([18F]FAZA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To show that use of "metabolic imaging" allows to decrease local relapses in patient with chordomas, focussing radiotherapy on the tumor's zone(s) with poor oxygen level.
    Diminution du risque de rechute dans les chordomes de la base du crâne, du rachis mobile et du sacrum traités par chirurgie et une protonthérapie de complément ciblée sur les cellules mal oxygénées mises en évidence par TEP-scan au [18F]-FAZA.
    A.3.2Name or abbreviated title of the trial where available
    PROTONCHORDE 01
    PROTONCHORDE 01
    A.4.1Sponsor's protocol code numberIC2014-16
    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 SponsorINSTITUT CURIE
    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 supportINSTITUT CURIE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CURIE
    B.5.2Functional name of contact pointGASTRIN Chrystelle
    B.5.3 Address:
    B.5.3.1Street Address26, rue d'Ulm
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number00331.56.24.56.30
    B.5.5Fax number00331.53.10.40.29
    B.5.6E-mailchrystelle.gastrin@curie.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 No
    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 name1-(5- [18F]-fluoro-5-desoxy-α-arabinofuranosyl)-2-nitroimidazole
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 Yes
    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
    Chordomas of the skull base, spine and sacrum
    Chordomes de la base du crâne, du rachis et du sacrum.
    E.1.1.1Medical condition in easily understood language
    Base of the skull, spine and sacrum's tumor.
    Tumeur de la base du crâne, du rachis et du sacrum
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement of local control with proton beam irradiation, optimized on the hypoxic component of the chordoma, as determined by PET/CT [18F]FAZA.
    Amélioration du contrôle local avec une irradiation par un faisceau de protons, optimisé sur la zone hypoxique du chordome, déterminée par TEP/TDM [18F]FAZA
    E.2.2Secondary objectives of the trial
    -Toxicity evaluation,
    - Evaluation of metabolic response to treatment through PET/CT exams with [18F]FDG and [18F]FAZA with regards to semi-quatitative criterias of standard uptake value (SUV) measurements and PERCIST criterias.
    - Evaluation of overall survival,
    - Correlation between the hypoxic zones (distribution of [18F]FAZA) and the different biological factors (HIF, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3)
    - Correlation between glucose metabolism [18F]FDG PET/CT and the hypoxic component [18F]FAZA PET/CT
    - constitutional and tumoral genetic sequencing
    - Development of an animal model (Interspecies transplant)
    - Evaluation de la toxicité
    - Evaluation de la réponse métabolique au traitement par les examens TEP/TDM au [18F]FDG et [18F]FAZA selon les critères semi-quantitatifs des mesures de la valeur d’absorption standard (SUV) et critères PERCIST
    - Evaluation de la survie globale
    - Evaluation de l’association entre les zones hypoxiques (mises en évidence par le [18F]FAZA) et les différents facteurs de régulation du métabolisme tumoral sous hypoxie (HIF1, HIF2, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3)
    - Evaluation de l’association entre le métabolisme du glucose [18F]FDG (+) et la composante hypoxique [18F]FA
    - Séquençage génétique tumoral et constitutionnel
    - Elaboration d’un modèle animal (xénogreffe)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Typical chordomas and chondroid chordomas of the skull base, spine and sacral region with Incomplete and/or split up exerese ( non mono-bloc exerese)
    - Patient for whom an additonal prothontherapy treatment is relevant
    - Age≥ 18 years old, KI > 80%, life expectancy > 3years (lower limit),
    - ECOG performance status 0 to 2
    - satisfying biological functions 14 days before inclusion :
    a. Haemoglobin ≥ 9 g/dL
    b. Neutrophils ≥ 1500/mm3
    c. Platelets ≥ 100 000/mm3
    d. ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubine ≤ 40 µmol/L, LDH ≤ 1.5 N
    e. Creatininemia < 1.5 N
    - Absence of metastases
    - Satisfying cardiac, lung, neurologic funtions ou well stabilised
    - Hematologic, hepatic and renal function: Normal (defined in the protocol)
    - Vital functions (cardiac, respiratory, neurologic): Normal or well stabilized
    - Prior treatments: no prior history of cerebral radiotherapy, neither of the skull base, nor of the spinal segment to be treated
    - Patient covered by health insurance
    - Effective contraception for women of childbearing age during the length of the protontherapy treatment and for the month following the end of treatment. A pregnancy test shall be negative at inclusion.
    - Patient provided with information and signature of informed consent.
    - Chordomes typiques et chordomes chondroïdes de la base du crâne, du rachis et de la région sacrée en exérèse incomplète et/ou fragmentée (exérèse non mono-bloc)
    - Patient relevant d’un traitement de complément par protonthérapie
    - Age ≥ 18 ans, KI >80%, espérance de vie > à 3 ans (limite la plus basse)
    - ECOG performance status 0 à 2
    - Fonctions biologiques satisfaisante 14 jours avant l’inclusion :
    a. Hémoglobine ≥ 9 g/dL
    b. Polynucléaires neutrophiles ≥ 1500/mm3
    c. Plaquettes ≥ 100 000/mm3
    d. ASAT, ALAT, GGT, PAL ≤ 1.5 N, bilirubine ≤ 40 µmol/L, LDH ≤ 1.5 N
    e. Créatininémie < 1.5 N
    - absence de metastases
    - Fonctions cardiaque, respiratoire, neurologique satisfaisantes ou bien stabilisées
    - fonctions hématologiques, hépatiques et rénales normales (définies dans le protocole)
    - traitements antérieurs : pas d’antécédent de radiothérapie cérébrale, ni de la base du crâne, ni du segment du rachis à traiter.
    - Patient bénéficiant d’un régime de sécurité sociale
    - Pour les femmes en âge de procréer, méthode de contraception adaptée pendant toute la durée de la protonthérapie et 1 mois après la fin de ce traitement. Un test de grossesse (dosage β-HCG sérique) devra être négatif à l’inclusion.
    - Signature du formulaire de consentement éclairé
    E.4Principal exclusion criteria
    - Dedifferentiated chordomas, chondrosarcomas, chrodomas of the sacral region with complete and mono-bloc exerese.
    - Metastatic patient
    - Contraindications to radiotherapy
    - Contraindications to PET/CT examinations [18F]FDG PET/CT and [18]FAZA PET/CT
    - Associated pathology likely to prevent the patient from receiving treatment,
    - History of cancer (except cutaneous basocellular epithelioma or epithelioma of the uterine cervix) having recurred in the 5 years preceding entry in the trial,
    - Patient already included in another therapeutic trial with an experimental medication
    - history of brain radiation therapy, or base of the skull or spinal segments to be treated
    - incompatible treatment with the inclusion in the study (oxygen therapy, EPO, anti-vascular treatments, anti-angiogenic tretaments)
    - Pregnancy, or possibility of pregnancy, or currently nursing,
    - Persons deprived of their liberty, or under guardianship,
    - Impossibility of undergoing the trial’s medical follow-up for geographical, social or psychological reasons.
    - Chordomes dédifférenciés, chondrosarcomes, chordomes de la région sacrée en exérèse mono-bloc et complète
    - Patient métastatique
    - Contre-indication à la radiothérapie
    - Contre-indication à des examens TEP/TDM au [18F]-FDG et/ou au [18F]-FAZA
    - Pathologie associée susceptible d'empêcher le patient de recevoir le traitement.
    - Antécédent de cancer (sauf carcinomes basocellulaires ou épidermoïdes cutanés ou des carcinomes du col utérin non invasifs) dans les 5 ans précédant l’entrée dans l’essai et n’ayant pas récidivé dans les 3 dernières années
    - Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale.
    - Antécédent de radiothérapie cérébrale, ou de la base du crâne, ou du segment rachidien à traiter
    - Traitements incompatibles avec l’inclusion dans l’essai (oxygénothérapie, EPO, anti-vasculaires, anti-angiogéniques)
    - Femme enceinte (ou susceptible de l’être) ou en cours d'allaitement.
    - Personne privée de liberté ou sous tutelle.
    - Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychologiques.
    E.5 End points
    E.5.1Primary end point(s)
    Local control according to RECIST criteria.
    Contrôle local selon les critères RECIST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mois
    E.5.2Secondary end point(s)
    -Toxicity evaluation according to NCI CTC-AE version 4.
    - Evaluation of metabolic response to treatment through PET/CT exams with [18F]FDG and [18F]FAZA with regards to semi-quatitative criterias of standard uptake value (SUV) measurements and PERCIST criterias.
    - Evaluation of overall survival.
    - Correlation between the hypoxic zones (distribution of [18F]FAZA) and the different biological factors (HIF, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3)
    - Correlation between glucose metabolism [18F]FDG PET/CT and the hypoxic component [18F]FAZA PET/CT
    - constitutional and tumoral genetic sequencing
    - Development of an animal model (Interspecies transplant)
    - Evaluation de la toxicité selon les critères NCI CTCAE version 4.
    - Evaluation de la réponse métabolique au traitement par les examens TEP/TDM au [18F]FDG et [18F]FAZA selon les critères semi-quantitatifs des mesures de la valeur d’absorption standard (SUV) et critères PERCIST
    - Evaluation de la survie globale
    - Evaluation de l’association entre les zones hypoxiques (mises en évidence par le [18F]FAZA) et les différents facteurs de régulation du métabolisme tumoral sous hypoxie (HIF1, HIF2, CA IX, CA XII, MCT1, MCT4, CD147, GLUT, Bnip3)
    - Evaluation de l’association entre le métabolisme du glucose [18F]FDG (+) et la composante hypoxique [18F]FA
    - Séquençage génétique tumoral et constitutionnel
    - Elaboration d’un modèle animal (xénogreffe)
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    End of the trial happens 3 years after end of radiotherapy (earlier in case of local relapse)
    La fin de l'essai pour un patient est au plus tard 3 ans après la fin du traitement par radiothérapie ou au moment d'une éventuelle rechute.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state64
    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. Patient are followed according to standard practice.
    Aucun. Les patients sont suivi selon les modalités habituelles dans cette pathologie.
    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 Decision2016-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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