Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Multicentre pilot-study for the therapy of medulloblastoma of adults (NOA-07) Phase II

    Summary
    EudraCT number
    		 2007-002560-10
    Trial protocol
    		 DE  
    Global end of trial date
    12 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    Summary report(s)
    		 NOA 07 DSUR 2018_Last
    NOA 07 short synopsis (German)
    NOA 07_Publication of Results incl AE´s SAE

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NOA-07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01614132
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Regensburg
    Sponsor organisation address
    Franz-Josef-Strauss-Allee 11, Regensburg, Germany, 93053
    Public contact
    Prof. Peter Hau, University of Regensburg Department Neurology, +49 9419448083, peter.hau@ukr.de
    Scientific contact
    Prof. Peter Hau, University of Regensburg Department Neurology, +49 9419448083, peter.hau@ukr.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far. The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity. In addition, the maximum number of cycles that are feasible shall be determined. Primary outcome measure: Tolerability of additional maintenance chemotherapy, which in combination with radiation has achieved the best therapeutic results to date. Secondary outcome measures: Secondary outcome measures relate to additional safety and efficacy parameters as well as evaluation of imaging, histologic, and molecular parameters and assessment of cognitive performance, quality of life, and social outcome.
    Protection of trial subjects
    not applicable
    Background therapy
    		 not applicable
    Evidence for comparator
    		 Rationale of the study Primary aim of the NOA-07 study was to evaluate the toxicity of adjuvant chemotherapy with cisplatin, lomustine and vincristine in adults > 18 years of age with medulloblastoma in a controlled prospective setting. In children with medulloblastoma, the introduction of adjuvant chemotherapy with cisplatin, lomustine and vincristine led to a significant improvement of the overall survival to a 5-year OS rate of >80 % (Packer et al., 1994), (Packer et al., 1999). In adults, less and heterogeneous data existed, showing survival times varying between 26%-83% with various regimes in retrospective series. The only available prospective observation concerning adjuvant chemotherapy with cisplatin, lomustine and vincristine derived from the HIT88/89/91 study: 46 adults (age 16-51 years, median 21 years) were treated within the protocol reaching overall a 5y-PFS of 63% (n=46) and a 5y-PFS of 71% in cases of M0-situation (n=18) - a result that appeared promising and required prospective randomised trials for further validation. However, toxicity concerns were raised when dealing with intensive adjuvant chemotherapy. In children, up to 60% of patients require dose modification. In adults, very little was known about the toxicity of the combination therapy. It was not possible to simply transfer the results from children to adults due to differing age-dependent chemotherapy sensitivities. Accordingly, the scope of the NOA-07 trial was to accurately evaluate toxicity of an adjuvant treatment with cisplatin, lomustine, vincristine in a phase II study before planning a phase III trial on the efficacy on adjuvant chemotherapy in adult medulloblastoma.
    Actual start date of recruitment
    01 Jan 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 First Patient in: 26.01.2009; Last Patient in: 29.04.2014-Germany

    Pre-assignment
    Screening details
    		 Medulloblastoma (+/- postoperative residual tumor, M0) or Medulloblastoma (+/- postoperative residual tumor, M1-3). Age: completed 18 years of age The diagnosis for this is made by the local pathologist, it must be confirmed immediately at study inclusion by reference histology

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 -
    Arm type
    		 test

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    1.5mg/m² weekly, cap at 2.0mg during radiation (6 week peroid). followed by a maximum of 8 six-weekly cycles of 1.5mg/m² cap at 2.0mg days 1,8 and 15

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    70.0mg/m² on Day 1 during a maximum of 8 six-weekly cycles

    Investigational medicinal product name
    Cecenu (Lomustin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75.0mg/m² on Day 1 during a maximum of 8 six-weekly cycles

    Number of subjects in period 1
    		Single Arm
    Started
    30
    Completed
    30

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 30 30
    Age categorical
    Age 18 and over
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Age 18 and over
    		 30 30
    Age continuous
    Units: years
        median (full range (min-max))
    		 37.2 (21.7 to 53.7) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 19 19

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 -

    Primary: rate of toxicity-related treatment terminations

    		 Close Top of page
    End point title
    		 rate of toxicity-related treatment terminations [1]
    End point description
    End point type
    Primary
    End point timeframe
    after 4 chemotherapy cycles
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this single arm trial, no inferential statistics were done. The primary endpoint is solely descriptive regarding safety.
    End point values
    		 Single Arm
    Number of subjects analysed
    25
    Units: whole
    25
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse Events were reported as soon as Patient signed informed consent.Adverse. During telefone calls. The first 10 weeks at least on a weekly basis after that Day 1, 8 and 15 on site in every cycle during entire tiral period until resolved or end of FU
    Adverse event reporting additional description
    See Table 4 on uploaded Publication.Adverse Events listed Grades 1-4. The main objective of the trial was to determine the number of interruptions due to toxicity.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attached document for results

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the small number of remaining evaluable patients, a meaningful evaluation of the PFS at the 5 year time point was no longer possible. The trial was terminated at the 3 year PFS time point instead.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 00:35:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA