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    Clinical Trial Results:
    Assessment of histopathological response to combination chemotherapy with Oxaliplatin, Irinotecan, Fluorouracil and Bevacizumab in patients with peritoneal metastasis from colorectal cancer (CARCINOSIS).

    Summary
    EudraCT number
    		 2015-002917-30
    Trial protocol
    		 AT  
    Global end of trial date
    16 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Sep 2020
    First version publication date
    05 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CARCINOSIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    Department of Surgery, Medical University of Vienna, 0043 14040056210, thomas.bachleitner-hofmann@meduniwien.ac.at
    Scientific contact
    Department of Surgery, Medical University of Vienna, 0043 14040056210, thomas.bachleitner-hofmann@meduniwien.ac.at
    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
    10 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to prospectively assess the histopathological response to neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab in peritoneal tumor deposits of 30 patients with pcCRC by determining the % of viable tumor cells (vtc) in the resected specimen after neoadjuvant chemotherapy using standard pathology.
    Protection of trial subjects
    For reasons of comprehensive view, in the following section a list of adverse events from a clinical trial investigating the FOLFOXIRI + Bevacizumab treatment regimen in patients with metastatic colorectal cancer is provided. The complete listings are included in the Summary of Product Characteristics of Fluorouracil Accord, rev. 02/2014, the Summary of Product Characteristics of Calciumfolinat "Ebewe", rev. 01/2015, the Summary of Product Characteristics of Irinotecan Fresenius, rev. 11/2013, the Summary of Product Characteristics of Oxaliplatin Accord, rev. 04/2012 and the Summary of Product Characteristics of Avastin, rev. 03/2015.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    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
    Austria: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    3
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After signing the informed consent form all patients will be screened and baseline procedures performed from 28 days to 1 day prior to surgical exploration, Signed informed consent, Demographics and medical history, Concomitant medications, Physical examination, Vital signs, ECOG perfomance status,12 lead ECG, Laboratory tests, Urinalysis,Tumor mar

    Pre-assignment period milestones
    Number of subjects started
    		 8
    Number of subjects completed
    		 8

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

    Arms
    Arm title
    		 Assessment of histopathological response to combination chemot
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluorouracil Accord
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fluorouracil is supplied as a clear, colourless liquid. The pH ranges from 8.6 -9.4. The formulation contains 50 mg Fluorouracil/1ml, sodium hydroxide, hydrochloric acid and water for injection (WFI).

    Investigational medicinal product name
    Calciumfolinat "Ebewe"
    Investigational medicinal product code
    Other name
    LEUCOVORIN CALCIUM
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin is supplied as a clear, colourless to sligthly yellow liquid. The pH ranges from 6.5 – 8.5. The formulation contains 12.71 mg Calciumfolinat .5 H2O (corresponding to 10 mg folinic acid) and water for injection (WFI).

    Investigational medicinal product name
    Irinotecan Fresenius
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan is supplied as a clear, sligthly yellow liquid. The formulation contains 20 mg Irinotecanhydrochloride-Trihydrate/1ml, sorbitol (E 420), lactic acid, sodium hydroxide, hydrochloric acid and water for injection (WFI).

    Investigational medicinal product name
    Oxaliplatin Accord
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intracavernous use
    Dosage and administration details
    Oxaliplatin is supplied as a clear, colourless sterile liquid. The pH ranges from 3.5-6.5. The formulation contains 5mg Oxaliplatin/1ml, lactose-monohydrate and water for injection (WFI).

    Investigational medicinal product name
    AVASTIN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab is supplied as a clear to slightly opalescent, colourless to pale brown, sterile liquid for intravenous infusion in single-use vials which are preservative-free. Bevacizumab will be supplied either in 5 mL (100 mg, 25 mg/ml) glass vials with a 4 ml fill, or in 20 ml (400 mg, 25 mg/ml) glass vials with a 16 ml fill. The formulation contains sodium phosphate, trehalose, polysorbate 20, and sterile water for injection (SWFI), USP.

    Number of subjects in period 1
    		Assessment of histopathological response to combination chemot
    Started
    8
    Completed
    6
    Not completed
    2
         Death
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Assessment of histopathological response to combination chemot
    Reporting group description
    		 -

    Reporting group values
    		 Assessment of histopathological response to combination chemot Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary objective of the study is to prospectively assess the histopathological response to neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab in peritoneal tumor deposits of 30 patients with pcCRC by determining the percentage of viable tumor cells in the resected specimen after neoadjuvant chemotherapy. For patients with multiple peritoneal specimens, the median percentage of viable cells in all specimens will be used. Patients with 0-49% of viable cells will be considered as responders. The timepoint of the assessment of the primary objective will be during re-exploratory surgery/surgical cytoreduction between days 78 and 106 of the treatment phase of the study. We hypothesize that there will be >30% responders after neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab.

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    8
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    3
        From 65-84 years
    5
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    5

    End points

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    End points reporting groups
    Reporting group title
    Assessment of histopathological response to combination chemot
    Reporting group description
    		 -

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary objective of the study is to prospectively assess the histopathological response to neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab in peritoneal tumor deposits of 30 patients with pcCRC by determining the percentage of viable tumor cells in the resected specimen after neoadjuvant chemotherapy. For patients with multiple peritoneal specimens, the median percentage of viable cells in all specimens will be used. Patients with 0-49% of viable cells will be considered as responders. The timepoint of the assessment of the primary objective will be during re-exploratory surgery/surgical cytoreduction between days 78 and 106 of the treatment phase of the study. We hypothesize that there will be >30% responders after neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab.

    Primary: Histopathological response to chemotherapy with FOLFOXIRI + bevacizumab

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    End point title
    		 Histopathological response to chemotherapy with FOLFOXIRI + bevacizumab [1]
    End point description
    End point type
    Primary
    End point timeframe
    During Re-exploratory/surgical cytoreduction (3 to 5 weeks after completion of chemotherapy (days 78 to 106))
    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: no comparision between arms. no statistical analysis performed due to premature termination.
    End point values
    		 Assessment of histopathological response to combination chemot
    Number of subjects analysed
    8
    Units: whole
        responder
    5
        non-responder
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    31.3.2016 until 10.1.2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    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
    6 / 8 (75.00%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    1
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urogenital infection bacterial
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    Injury, poisoning and procedural complications
    Heat exhaustion
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nervous system disorders
    Speech disorder
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Fever
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Eye disorders
    Ocular hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Diarrhea
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    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
    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.

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