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    Clinical Trial Results:
    Significance of prognostic and predictive factors for the efficacy and safety of neoadjuvant chemotherapy in combination with chemoradiation administered in patients with locally advanced cervical cancer.

    Summary
    EudraCT number
    		 2008-006309-17
    Trial protocol
    		 LT  
    Global end of trial date
    01 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jan 2022
    First version publication date
    15 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A7-14.
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institute of Oncology of Vilnius University
    Sponsor organisation address
    Santariskiu 1, Vilnius, Lithuania,
    Public contact
    Lina Daukantiene, Institute of Oncology of Vilnius University, 00370 52786709, lina.daukantiene@nvi.lt
    Scientific contact
    Lina Daukantiene, Institute of Oncology of Vilnius University, 00370 52786709, lina.daukantiene@nvi.lt
    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
    01 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the efficacy of treatment with neoadjuvant cisplatin+gemcitabine based chemotherapy and with concurrent cisplatin+gemcitabine+radiotherapy in locally advanced cervical cancer (defined as response to treatment and progression free survival); 2. To evaluate treatment safety.
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Lithuania: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    35
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women with locally advanced stage IIB-IIIB cervical cancer.

    Pre-assignment
    Screening details
    		 36 subjects previously received no treatment for cervical cancer

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 NA
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Concentrate for solution for infusion
    Dosage and administration details
    125 mg/m2 gemcitabin was given on once a week basis for 4 weeks as a neoadjuvant chemotherapy. 125mg /m2 gemcitabin was given on once a week basis during external beam radiotherapy for 5 weeks

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    30 mg/m2 cisplatin was given on once a week basis for 4 weeks as a neoadjuvant chemotherapy. 40mg /m2 cisplatin was given on once a week basis during external beam radiotherapy for 5 weeks

    Number of subjects in period 1
    		Overall trial
    Started
    36
    Completed
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Overall trial

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 36 36
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 35 35
        From 65-84 years
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 36 36
    Subject analysis sets

    Subject analysis set title
    Neoadjuvant chemotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients who received neoadjuvant chemotherapy

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled patients who received neoaddjuvant chemotherapy followd by chemoradiation.

    Subject analysis sets values
    		 Neoadjuvant chemotherapy Overall trial
    Number of subjects
    36
    36
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    36
    36

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 NA

    Subject analysis set title
    Neoadjuvant chemotherapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All enrolled patients who received neoadjuvant chemotherapy

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled patients who received neoaddjuvant chemotherapy followd by chemoradiation.

    Primary: Overall response rate

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    End point title
    		 Overall response rate
    End point description
    End point type
    Primary
    End point timeframe
    12 APR 2010 - 01 OCT 2013
    End point values
    		 Overall trial Neoadjuvant chemotherapy Overall trial
    Number of subjects analysed
    36
    36
    36
    Units: Percent
    36
    36
    36
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Frequencies and percentages were used for the categorical measures.
    Comparison groups
    Overall trial v Overall trial v Neoadjuvant chemotherapy
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 descriptive statistics
    Confidence interval
    Notes
    [1] - Frequencies and percentages were used for the categorical measures.
    [2] - Statistical hypothesis test was not performed

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 APR 2010 - 01 OCT 2013
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 36 (2.78%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Grade III
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 36 (100.00%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    36 / 36 (100.00%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    36 / 36 (100.00%)
         occurrences all number
    17
    Thrombocytopenia
         subjects affected / exposed
    36 / 36 (100.00%)
         occurrences all number
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    36 / 36 (100.00%)
         occurrences all number
    3

    More information

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    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.
    None reported
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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
    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.

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