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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2004-002503-33
    Sponsor's Protocol Code Number:GC 2005 04
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-04
    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 ConcernedIreland - HPRA
    A.2EudraCT number2004-002503-33
    A.3Full title of the trial
    PROTOCOL FOR THE TREATMENT OF EXTRACRANIAL GERM CELL TUMOURS
    IN CHILDREN AND ADOLESCENTS (GC III)
    A.3.2Name or abbreviated title of the trial where available
    GC III
    A.4.1Sponsor's protocol code numberGC 2005 04
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOur Lady's Hospital for Sick Children
    B.1.3.4CountryIreland
    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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Etoposide
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameEtoposide
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtoposide
    D.3.9.1CAS number 33419-42-0
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSYNTHETIC CHEMICAL
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Carboplatin
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namecarboplatin
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSYNTHETIC CHEMICAL
    D.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Bleomycin
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBleomycin
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBleomycin
    D.3.9.1CAS number 11056-06-7
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSYNTHETIC CHEMICAL
    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
    Extracranial germ cell tumours
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To stratify and reduce treatment for patients with extracranial germ cell tumours according to prognostic factors derived from analysis of UKCCSG Study GC8901 (GCII) whilst maintaining event free survival (EFS)
    E.2.2Secondary objectives of the trial
    To continue to treat newly diagnosed patients with extracranial germ cell tumours requiring chemotherapy with a Carboplatin based strategy
    To develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumours
    To register all cases of mature and immature teratoma
    To develop a common strategy for the management of immature and mature teratoma including follow-up strategies to permit early detection of yolk sac recurrence
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Newly diagnosed extracranial malignant germ cell tumour or mature/immature
    teratoma. All tumours must be histologically proven with or without raised
    AFP/HCG. Exceptional cases with unequivocally raised AFP/HCG and where the
    risk of biopsy is felt to be high can be diagnosed on clinical grounds, imaging and
    markers.
    ii) Patients with relapsed or progressing extracranial MGCT if previously treated with
    JEB chemotherapy
    iii) Age 0 – 18 years (i.e. up to but not including 18th birthday - but see Guidelines for Adolescents Section 8.3.4)
    iv) Blood count with neutrophil count > 1 x 109/L and platelet count > 100 x 109/L
    v) Liver function: Bilirubin < 2 x upper limit laboratory normal, ALT < 3 x upper limit laboratory normal
    vi) National and local ethical approval
    vii) Written and verbal informed patient/parent consent
    E.4Principal exclusion criteria
    Absence of inclusion criteria plus:
    i) Pregnant or lactating females
    ii) Intracranial GCTs
    iii) Patients receiving prior chemotherapy other than JEB. Patients relapsing following
    JEB are eligible for the relapse strategy (see above).
    E.5 End points
    E.5.1Primary end point(s)
    Low risk patients: Relapse rate will be monitored, based on the 12-month event rate (defined as relapse, progression or death). After the first 10 patients are included in the study with a minimum of 12 months’ follow up, analysis will be carried out. The stopping boundary will be crossed if 7 or more than 7 events are observed. If 6 or fewer than 6 events are observed accrual will continue and a second analysis will be carried out when a further 10 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 10 or more than 10 events are observed. If 9 or fewer than 9 events are observed accrual will continue and a third analysis will be carried out when a further 10 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 12 or more than 12 events are observed. If 11 or fewer than 11 events are observed accrual will continue and a fourth analysis will be carried out when a further 10 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 15 or more than 15 events are observed. If 14 or fewer than 14 events are observed accrual will continue and a final analysis will be carried out when the 50 patients are included in the study and have a minimum of 12 months’ follow up. The relapse rate would be significantly higher than previously if 17 or more than 17 events are observed .
    Intermediate risk patients: It is anticipated 4 patients per year would be included in the intermediate risk group of patients. The reduction in the number of courses of chemotherapy may lead to a higher relapse rate and so a stopping rule to prevent an excess of relapses or progressions in patients entering the study will be used. The rule is based on monitoring the 12-month event rate. After the first 4 patients are included in the study with a minimum of 12 months’ follow up, analysis will be carried out. The stopping boundary will be crossed if 3 or more than 3 events are observed. If 2 or fewer than 2 events are observed accrual will continue and a second analysis will be carried out when a further 4 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 3 or more than 3 events are observed. If 2 or fewer than 2 events are observed accrual will continue and a third analysis will be carried out when a further 4 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 3 or more than 3 events are observed. If 2 or fewer than 2 events are observed accrual will continue and a fourth analysis will be carried out when a further 4 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 3 or more than 3 events are observed. If 2 or fewer than 2 events are observed accrual will continue and a final analysis will be carried out when the 20 patients are included in the study and have a minimum of 12 months’ follow up. The relapse rate would be significantly higher than before if 4 or more than 4 events are observed.
    High risk patients: It is anticipated 7 patients per year would be included in the high-risk group of patients. The protocol treatment for high-risk patients is similar to before, but the relapse rate will be monitored, with a stopping rule to prevent an excess of relapses or progressions in these patients. The rule is based on monitoring the 12-month event rate. After the first 7 patients are included in the study with a minimum of 12 months’ follow up, analysis will be carried out. The stopping boundary will be crossed if 7 events are observed . If 6 or fewer than 6 events are observed accrual will continue and a second analysis will be carried out when a further 7 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 9 or more than 9 events are observed. If 8 or fewer than 8 events are observed accrual will continue and a third analysis will be carried out when a further 7 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 11 or more than 11 events are observed. If 10 or fewer than 10 events are observed accrual will continue and a fourth analysis will be carried out when a further 7 patients are included in the study and have a minimum of 12 months’ follow up. The stopping boundary will be crossed if 13 or more than 13 events are observed. If 12 or fewer than 12 events are observed accrual will continue and a final analysis will be carried out when the 35 patients are included in the study and have a minimum of 12 months’ follow up. The relapse rate would be significantly higher than before if 15 or more than 15 events are observed.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Accrual of target number of patients
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and infants who are not Gillick competent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2006-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-08
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