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    Summary
    EudraCT Number:2021-003275-34
    Sponsor's Protocol Code Number:UHFRT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003275-34
    A.3Full title of the trial
    TEMOZOLOMIDE + ULTRA-HYPER-FRACTIONATED RADIOTHERAPY VS TEMOZOLOMIDE ALONE FOR THE MAINTENANCE TREATMENT OF GLIOBLASTOMA PATIENTS - PILOT STUDY
    Temozolomide + radioterapia ultra-iper-frazionata rispetto a solo temozolomide per il trattamento di mantenimento dei pazienti affetti da glioblastoma: uno studio pilota.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TEMOZOLOMIDE + ULTRA-HYPER-FRACTIONATED RADIOTHERAPY VS TEMOZOLOMIDE ALONE FOR THE MAINTENANCE TREATMENT OF GLIOBLASTOMA PATIENTS - PILOT STUDY
    Temozolomide + radioterapia ultra-iper-frazionata rispetto a solo temozolomide per il trattamento di mantenimento dei pazienti affetti da glioblastoma: uno studio pilota
    A.3.2Name or abbreviated title of the trial where available
    Ultra Hyper Fractionated Radiatherapy as a maintenance treatment for glioblastoma
    Radioterapia Ultra Iper Frazionata come trattamento di mantenimento del glioblastoma
    A.4.1Sponsor's protocol code numberUHFRT
    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 SponsorIRCCS-A.O.U. SAN MARTINO-IST
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS OSPEDALE POLICLINICO SAN MARTINO
    B.5.2Functional name of contact pointCENTRO CLINICAL TRIALS
    B.5.3 Address:
    B.5.3.1Street AddressLARGO R: BENZI, 10
    B.5.3.2Town/ cityGENOVA
    B.5.3.3Post code16132
    B.5.3.4CountryItaly
    B.5.4Telephone number0105558476
    B.5.5Fax number010354103
    B.5.6E-mailluca.boni@hsanmartino.it
    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.2.5The 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.3.2Product code [TMZ]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 85622-93-1
    D.3.9.2Current sponsor codeTMZ
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    histologically confirmed glioblastoma according to WHO criteria (grade IV).
    glioblastoma istologicamente confermato secondo i criteri WHO (gradoIV)
    E.1.1.1Medical condition in easily understood language
    Glioblastoma
    Glioblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect on overall survival (OS) of the maintenance treatment with TMZ + ultra-hyper-FRT vs TMZ alone in GB patients
    confrontare l'effetto sulla sopravvivenza globale nei pazienti affetti da glioblastoma del trattamento di mantenimento con temozolomide (TMZ) + radioterapia ultra-iperfrazionata rispetto al solo trattamento con TMZ
    E.2.2Secondary objectives of the trial
    To compare the effect on progression free survival (PFS) of the maintenance treatment with TMZ + ultra-hyper-FRT vs TMZ alone in GB patients.
    To evaluate early/late toxicities/complications by organ/severity.
    confrontare l'effetto sulla sopravvivenza libera da progressione nei pazienti affetti da glioblastoma, del trattamento di mantenimento con TMZ + radioterapia ultra-iperfrazionata rispetto al solo trattamento con TMZ.
    Valutare la tossicità del trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients (age =18 to =90 years).
    • Patients who have undergone maximal surgical resection.
    • Histologically confirmed diagnosis of GB according to WHO criteria (grade IV).
    • Completed 6-week TMZ + conv-FRT treatment ("Stupp" protocol).
    • Ability to correctly provide informed consent.
    • Karnofsky performance status > 70%
    • Radiation dose already received at critical areas such as optic chiasm, circle of Willis, hypothalamus, hippocampal areas, pituitary gland and cochleae sufficiently low to permit the delivery of the additional ultra-hyper-FRT dose (12.5 Gy/year).
    • Willingness to follow a long-term ultra-hyper-FRT treatment.
    • Ability to understand and willingness to sign a written informed consent.
    Pzienti adulti (età =18 =90 anni).
    • Pazienti sottoposti a resezione chirurgica massimale.
    • Diagnosi istologicamente confermata di GB secondo i criteri dell'OMS (grado IV).
    • Completato il trattamento di 6 settimane TMZ + conv-FRT (protocollo "Stupp").
    • Capacità di fornire correttamente il consenso informato.
    • Stato delle prestazioni di Karnofsky > 70%
    • Dose di radiazioni già ricevute in aree critiche come chiasma ottico, circolo di Willis, ipotalamo, aree dell'ippocampo, ghiandola pituitaria e coclee sufficientemente bassa da consentire l'erogazione della dose aggiuntiva ultra-iper-FRT (12,5 Gy/anno).
    • Disponibilità a seguire un trattamento ultra-iper-FRT a lungo termine.
    • Capacità di comprensione e disponibilità a firmare un consenso informato scritto.
    E.4Principal exclusion criteria
    Exclusion Criteria
    • Maximum tolerated radiation dose received at critical areas such as optic chiasm, circle of Willis, hypothalamus, hippocampal areas, pituitary gland and cochleae.
    • Pregnant and lactating women.
    • Pre-menopausal women of child-bearing potential and male with fertile partner who are not willing to employ effective contraception according to “2007 clinical trial facilitation group (CTFG) Recommendations related to contraception and pregnancy testing in clinical trials” from screening for all the duration of the study.
    • Any psychiatric, social or compliance issues that, in the treating physician opinion, will interfere with completion of the ultra-hyper-FRT treatment.
    •Massima dose di radiazioni tollerata ricevuta in aree critiche come chiasma ottico, circolo di Willis, ipotalamo, aree dell'ippocampo, ghiandola pituitaria e coclee.
    • Donne in gravidanza e in allattamento.
    • Donne in pre-menopausa in età fertile e uomini con partner fertile che non sono disposte a utilizzare una contraccezione efficace secondo le “Raccomandazioni del gruppo di facilitazione della sperimentazione clinica 2007 (CTFG) relative alla contraccezione e ai test di gravidanza negli studi clinici” dallo screening per tutta la durata dello studio.
    • Qualsiasi problema psichiatrico, sociale o di compliance che, nell'opinione del medico curante, interferirà con il completamento del trattamento ultra-iper-FRT.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival defined as the time from the date of randomization to the date of death from any cause.
    Sopravvivenza globale (OS) definita come il tempo dalla data di randomizzazione alla data di morte per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) defined as the time between the date of randomization and the date of the first documented occurrence of disease progression or the date of death, whichever comes first.
    Sopravvivenza libera da progressione (PFS) definita come il tempo che intercorre tra la data di randomizzazione e la data della prima comparsa documentata di progressione della malattia oppure la data di morte, a seconda di quale delle due si verifica per prima.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia standard
    Standard therapy
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Patients will continue to be followed up at the center according to normal clinical practice
    I pazienti continueranno ad essere seguiti presso il centro secondo normale pratica clinica
    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 Decision2021-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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