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    Clinical Trial Results:
    Predictive value of in-vitro testing anti-cancer therapy sensitivity on tumorspheres from patients with metastatic colorectal cancer

    Summary
    EudraCT number
    		 2017-000456-26
    Trial protocol
    		 DK  
    Global end of trial date
    23 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2022
    First version publication date
    30 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Tumorspheres_Colrec
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03251612
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark,
    Public contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    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
    31 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the present study is to investigate the benefit to patients with metastatic colorectal cancer of post standard anti-cancer therapy based on pretreatment in-vitro testing of drug sensitivity to patient-derived tumorspheres.
    Protection of trial subjects
    Antiemetics and other supportive treatment as necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2017
    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
    Denmark: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    20
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled from September 2017 to September 2020.

    Pre-assignment
    Screening details
    		 Adult patients were screened for inclusion if they had progressive metastatic colorectal cancer and had already been exposed to, or not considered candidates for, available therapies including fluoroupyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents and, if RAS/RAF wild-type, anti-EGFR agents.

    Pre-assignment period milestones
    Number of subjects started
    		 34
    Number of subjects completed
    		 34

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

    Arms
    Arm title
    		 Precision cohort
    Arm description
    		 Patients with one histopathologic tumor type, colorectal adenocarcinoma, are subdivided into treatment groups based on functional characteristics.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Targeted treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Drugs were given based on sentivity analysis of individual patient-derived tumoroids. The combination of vinorelbine and capecitabine was given in 3-weekly cycles as oral vinorelbine 80 mg/m2 (after a first cycle at 60 mg/m2) on day 1 and day 8 together with capecitabine 1000 mg/m2 (750 if age ≥ 65 years) twice daily on days 1-14 in 3-weekly cycles. Gemcitabine 1000 mg/m2 i.v. was given in 2-weekly cycles on day 1 together with capecitabine 1000 mg/m2 twice daily on days 1-7. Temozolomide 150 mg/m2 on days 1–5 was given with irinotecan 100 mg/m2 on days 1 and 15 every 28 days. The following drugs were given according to SPC: Regorafenib Olaparib TAS-102 Sorafenib Epirubicin FOLFIRI

    Number of subjects in period 1
    		Precision cohort
    Started
    34
    Completed
    34

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 34 34
    Age categorical
    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)
    		 20 20
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    Precision cohort
    Reporting group description
    		 Patients with one histopathologic tumor type, colorectal adenocarcinoma, are subdivided into treatment groups based on functional characteristics.

    Primary: PFS eight weeks (time frame 42-63 days) after start of treatment

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    End point title
    		 PFS eight weeks (time frame 42-63 days) after start of treatment [1]
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks after start of treatment
    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: This is a single arm study. There is no intra-study comparison.
    End point values
    		 Precision cohort
    Number of subjects analysed
    34
    Units: Number
    34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every 4 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Toxicity
    Reporting group description
    		 -

    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: Non-serious adverse events were not collected.
    Serious adverse events
    		 Toxicity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 34 (23.53%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    cancer progression
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    abdominal
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstruction
    Additional description: Obstruction of stent
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Toxicity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)

    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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