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    Clinical Trial Results:
    A prospective randomized phase II trial of FOLFIRINOX alone versus FOLFIRINOX followed by radiochemotherapy in patients with locally advanced, primarily inoperable pancreatic cancer

    Summary
    EudraCT number
    		 2012-001850-24
    Trial protocol
    		 AT  
    Global end of trial date
    19 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2025
    First version publication date
    25 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABCSG_P02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ABCSG
    Sponsor organisation address
    Nussdorfer Platz 8/12, Wien, Austria, 1190
    Public contact
    Trial Office, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.at
    Scientific contact
    Trial Office, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.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
    14 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate that in patients suffering from a primarily inoperable LAPC neoadjuvant chemotherapy followed by concurrent neoadjuvant radiochemotherapy is superior to neoadjuvant chemotherapy alone in terms of R0-resectability
    Protection of trial subjects
    A Data Monitoring Committee (DMC) was established to obtain patient safety. The responsibility of the DMC was to evaluate deviations of medical relevance and safety issues. The DMC decided whether or not the patient should continue the study treatment due to safety issues. Important protocol deviations (IPDs) include all deviations endangering the basal medical concept of the study jeopardizing the safety of the patient. Protocol deviations (PDs) include all other protocol deviations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 83
    Worldwide total number of subjects
    83
    EEA total number of subjects
    83
    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)
    51
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Originally, the recruitment phase was planned for 36 months and was prolonged to 54 months in the protocol amendment 4.0. The actual recruitment period lasted 55 months (May 2017 - Dec 2021).

    Pre-assignment
    Screening details
    		 Screening assessments to confirm eligibility had to be performed within 28 days prior to randomization unless otherwise indicated.

    Pre-assignment period milestones
    Number of subjects started
    		 83
    Number of subjects completed
    		 83

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Folfirinox alone
    Arm description
    		 6 months of neoadjuvant chemotherapy with Folfirinox (2 phases of three months each)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² as a 2-hours infusion

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    165 mg/m² as a 90-minutes infusion

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    CALCIUM FOLINATE, , Folinic acid (Leucovorin)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg/m² or 400 mg/m² given as a 2-hours infusion

    Investigational medicinal product name
    Fluorouracil
    Investigational medicinal product code
    Other name
    FLUORAOURACIL SODIUM
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2400 mg/m² as a 46-hours infusion

    Arm title
    		 Folfirinox + radiochemtherapy
    Arm description
    		 3 months of neoadjuvant chemotherapy with Folfirinox plus concurrent neoadjuvant radiochemotherapy (radiotherapy plus concomitant capecitabine) administered on 28 working days during a time period of a minimum of 38 days and a maximum of 47 days (capecitabine intake only on days of radiotherapy)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² as a 2-hours infusion

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    165 mg/m² as a 90-minutes infusion

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    CALCIUM FOLINATE, FOLINATE, Folinic acid (Leucovorin)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg/m² or 400 mg/m² given as a 2-hours infusion

    Investigational medicinal product name
    Fluorouracil
    Investigational medicinal product code
    Other name
    FLUORAOURACIL SODIUM
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2400 mg/m² as a 46-hours infusion

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    825 mg/m² twice daily

    Number of subjects in period 1
    		Folfirinox alone Folfirinox + radiochemtherapy
    Started
    41
    42
    Completed
    5
    6
    Not completed
    36
    36
         Adverse event, serious fatal
    30
    30
         Consent withdrawn by subject
    5
    3
         Study termination by the sponsor
    1
    -
         Lost to follow-up
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Folfirinox alone
    Reporting group description
    		 6 months of neoadjuvant chemotherapy with Folfirinox (2 phases of three months each)

    Reporting group title
    Folfirinox + radiochemtherapy
    Reporting group description
    		 3 months of neoadjuvant chemotherapy with Folfirinox plus concurrent neoadjuvant radiochemotherapy (radiotherapy plus concomitant capecitabine) administered on 28 working days during a time period of a minimum of 38 days and a maximum of 47 days (capecitabine intake only on days of radiotherapy)

    Reporting group values
    		 Folfirinox alone Folfirinox + radiochemtherapy Total
    Number of subjects
    		 41 42 83
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60.0 (44.0 to 78.0) 62.5 (44.0 to 78.0) -
    Gender categorical
    Units: Subjects
        Female
    		 15 17 32
        Male
    		 26 25 51
    Karnofsky Performance Scale
    Index to classify patients as to their functional impairment: 90%-100%: Fully active; able to carry on all pre-disease performance without restriction 70%-80%: Restricted in physically strenuous activity but ambulatory
    Units: Subjects
        70%-80%
    		 6 8 14
        90%-100%
    		 15 11 26
        Unknown
    		 20 23 43
    Eastern Cooperative Oncology Group (ECOG) performance status
    Scale to measure a cancer patient's level of physical functioning and daily activity Scale 0: Fully active, able to carry out all pre-disease performance without restriction Scale 1: Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work
    Units: Subjects
        Scale 0
    		 30 31 61
        Scale 1
    		 10 11 21
        Unknown
    		 1 0 1
    Electrocardiogram (ECG)
    Units: Subjects
        Abnormal, clinically significant
    		 2 2 4
        Abnormal, not clinically significant
    		 14 9 23
        Normal
    		 24 25 49
        Unknown
    		 1 6 7
    Tumor classification
    Units: Subjects
        Irresectable - borderline
    		 14 15 29
        Irresectable - locally advanced
    		 27 27 54
    Irresectability details
    Units: Subjects
        Arterial (HA, SMA) involvement
    		 6 5 11
        Arterial and venous (PV, SMV, HA, SMA) involvement
    		 20 24 44
        Cross infiltration of several vital structures
    		 5 4 9
        Venous (PV, SMV) involvement
    		 10 9 19
    T-stage
    T-stage is primarily determined by tumor size (AJCC/UICC 8th ed.). T4 is defined by the tumor's involvement of other structures. T1: Tumor is 2 cm or less in greatest dimension T2: Tumor is more than 2 cm but not more than 4 cm in greatest dimension T3: Tumor is more than 4 cm in greatest dimension T4: Tumor is unresectable due to invasion of major blood vessels, including the celiac axis and/or superior mesenteric artery
    Units: Subjects
        T1
    		 0 0 0
        T2
    		 8 10 18
        T3
    		 6 6 12
        T4
    		 8 7 15
        Unknown
    		 19 19 38
    N-stage
    N staging is based on the number of positive lymph nodes (AJCC/UICC 8th ed.) N0: No regional lymph node metastasis N1: Metastasis in one to three regional lymph nodes N2: Metastasis in four or more regional lymph nodes NX: not determinable
    Units: Subjects
        N0
    		 12 8 20
        N1
    		 8 10 18
        N2
    		 1 2 3
        NX
    		 0 3 3
        Unknown
    		 20 19 39
    M-stage
    M-stage indicates whether the cancer has spread to distant parts of the body (M1) or not (M0)
    Units: Subjects
        M0
    		 40 41 81
        M1
    		 1 1 2
    Body Mass Index (BMI)
    Units: Subjects
        Underweight
    		 4 1 5
        Normal weight
    		 19 20 39
        Overweight
    		 11 15 26
        Obesity
    		 7 6 13

    End points

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    End points reporting groups
    Reporting group title
    Folfirinox alone
    Reporting group description
    		 6 months of neoadjuvant chemotherapy with Folfirinox (2 phases of three months each)

    Reporting group title
    Folfirinox + radiochemtherapy
    Reporting group description
    		 3 months of neoadjuvant chemotherapy with Folfirinox plus concurrent neoadjuvant radiochemotherapy (radiotherapy plus concomitant capecitabine) administered on 28 working days during a time period of a minimum of 38 days and a maximum of 47 days (capecitabine intake only on days of radiotherapy)

    Primary: R0 resection rate

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    End point title
    		 R0 resection rate
    End point description
    R0 resection: (clear resection margin) defined as continuous tumor free rim of tissue of at least 1 mm to the entire circumferential resection margin R0: no tumor cells at margins Non R0: includes R1 patients (microscopic tumor cells at margins; 11), patients who were not evaluated (9) and patients without surgery (41)
    End point type
    Primary
    End point timeframe
    At surgery approx. 4.5 months (Folfirinox alone arm) or 6.4 months (Folfirinox + radiochemtherapy arm) after randomisation
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    41
    42
    Units: Subjects
        R0
    9
    13
        Non R0
    32
    29
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.353
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.9
         upper limit
    		 27.9

    Secondary: Tumor response by modified RECIST

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    End point title
    		 Tumor response by modified RECIST
    End point description
    Response Criteria in Solid Tumors (RECIST) v1.1 as standard approach to evaluation of study treatments for objective response Complete Response (CR): Disappearance of target lesion Partial Response (PR): At least 30% decrease of diameter of target lesion, taking as reference the baseline diameter of target lesion Progressive Disease (PD): At least a 20% increase in diameter of target lesion. Additionally, the diameter must also demonstrate an absolute increase of at least 5 mm Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD (reference: smallest diameter)
    End point type
    Secondary
    End point timeframe
    At surgery approx. 4.5 months (Folfirinox alone arm) or 6.4 months (Folfirinox + radiochemtherapy arm) after randomisation
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    41
    42
    Units: Subjects
        Complete Response (CR)
    0
    0
        Partial Response (PR)
    4
    13
        Progressive Disease (PD)
    1
    3
        Stable Disease (SD)
    11
    11
        Unknown
    25
    15
    Statistical analysis title
    		 Fishers Exact test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - Note that the category "Unknown" was included in the test which accounted for a large portion of the difference. Without including this category, the test is no longer significant, but still the differences in the response rates are remarkably large.

    Secondary: Histopathological tumor response

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    End point title
    		 Histopathological tumor response
    End point description
    Histo-pathological tumor response with respect to proportion of severely degenerative cancer cells Marked response: No residual tumor or rare, single cancer cells or small groups of cancer cells (glands) with marked cytopathic effect present within a fibrotic stroma Minimal to moderate response: Residual tumor present; includes small groups of cells/glands without evidence of cytopathic effect, cells/glands outside the main fibrotic mass, and/or >5% of the main fibrotic mass with cancer/gland, with or without cytopathic effect Poor response: No definite evidence of treatment effect; extensive (> 90%) residual cancer; only minimal cytopathic effect, and baseline fibrosis is present
    End point type
    Secondary
    End point timeframe
    At surgery approx. 4.5 months (Folfirinox alone arm) or 6.4 months (Folfirinox + radiochemtherapy arm) after randomisation
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    41
    42
    Units: Subjects
        Marked response
    6
    8
        Minimal to moderate response
    5
    7
        Poor response
    4
    2
        No assessment done
    5
    5
        No surgery
    21
    20
    Statistical analysis title
    		 Fishers Exact test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.88
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Perioperative complications

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    End point title
    		 Perioperative complications
    End point description
    Clavien and Dindo classification of surgical complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multi organ dysfunction Grade V: Death of a patient
    End point type
    Secondary
    End point timeframe
    At surgery approx. 4.5 months (Folfirinox alone arm) or 6.4 months (Folfirinox + radiochemtherapy arm) after randomisation
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    20 [2]
    22 [3]
    Units: Subjects
        Grade I
    0
    3
        Grade II
    0
    1
        Grade IIIa
    2
    1
        Grade IIIb
    1
    1
        Grade IVa
    0
    0
        Grade IVb
    0
    2
        Grade V
    1
    0
        No complications
    14
    11
        No assessment done
    1
    3
        Unknown
    1
    0
    Notes
    [2] - Only patients with surgeries included
    [3] - Only patients with surgeries included
    Statistical analysis title
    		 Fishers Exact test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.287
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Progression-free survival (PFS)

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    End point title
    		 Progression-free survival (PFS)
    End point description
    Progression free survival (PFS) is defined as the time interval during and after treatment until disease progression. For the purpose of this study, PFS was calculated in all participants from the date of randomization until the first clinical/radiological evidence of progression or recurrence of PDAC or death. Progressions after surgeries were not considered as events, because per documentation guideline progressions only had to be documented prior to surgery or in case no surgery was performed. Participants who were progression free were censored with the last contact date.
    End point type
    Secondary
    End point timeframe
    Approx. 36 months after the last patient performed the end-of-treatment visit (28-35 days after surgery)
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    41
    42
    Units: months
        median (confidence interval 95%)
    10.1 (4.7 to 15.0)
    7.2 (5.9 to 10.4)
    Statistical analysis title
    		 Log-rank test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7533
    Method
    		 Logrank
    Confidence interval

    Secondary: Disease-free survival (DFS)

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    End point title
    		 Disease-free survival (DFS)
    End point description
    Disease free survival (DFS) is defined as the length of time after surgery for pancreatic ductal adenocarcinoma during which a participants survives with no evidence of the disease. For the purpose of this study, DFS was calculated in participants undergoing R0 pancreatic resection as the time from the date of surgery until the first clinical/radiological evidence of recurrence of PDAC or death (secondary cancers were not included). Participants who were event free were censored with the last contact date. Participants with metastatic disease (M1) at surgery were included with event day = 1. Survival rate estimates at 36 months with 2-sided 95% confidence intervals were calculated using the Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    Approx. 36 months after the last patient performed the end-of-treatment visit (28-35 days after surgery)
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    9
    13
    Units: percent
        number (confidence interval 95%)
    33.3 (7.8 to 62.3)
    23.1 (5.6 to 47.5)
    Statistical analysis title
    		 Log-rank test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8299
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival (OS) was calculated in all participants included in the study from the date of randomization until death from any cause. Participants without death date were censored with the end of follow up / last contact date.
    End point type
    Secondary
    End point timeframe
    Approx. 36 months after the last patient performed the end-of-treatment visit (28-35 days after surgery)
    End point values
    		 Folfirinox alone Folfirinox + radiochemtherapy
    Number of subjects analysed
    41
    42
    Units: months
        median (confidence interval 95%)
    21.4 (15.8 to 25.4)
    19.3 (12.1 to 28.2)
    Statistical analysis title
    		 Log-rank test
    Comparison groups
    Folfirinox alone v Folfirinox + radiochemtherapy
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7659
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start: date of the first dose of the study treatment; End: 28 days after the last dose of the study treatment
    Adverse event reporting additional description
    ABCSG P02 Treatment Emergent Adverse Events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Radiochemotherapy
    Reporting group description
    		 -

    Reporting group title
    Folfirinox
    Reporting group description
    		 -

    Serious adverse events
    		 Radiochemotherapy Folfirinox
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 42 (47.62%)
    22 / 41 (53.66%)
         number of deaths (all causes)
    30
    30
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Subclavian vein thrombosis
    Additional description: Subclavian vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
    Additional description: Jugular vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
    Additional description: Venous thrombosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
    Additional description: Device dislocation
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastroenteritis radiation
    Additional description: Gastroenteritis radiation
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
    Additional description: Concussion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
    Additional description: Pancytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer perforation
    Additional description: Anastomotic ulcer perforation
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
    Additional description: Ileus paralytic
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    4 / 42 (9.52%)
    5 / 41 (12.20%)
         occurrences causally related to treatment / all
    5 / 5
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    Additional description: Hepatic failure
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
    Additional description: Portal vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
    Additional description: Cholestasis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
    Additional description: Cholangitis
         subjects affected / exposed
    2 / 42 (4.76%)
    5 / 41 (12.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biloma
    Additional description: Biloma
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
    Additional description: Renal vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haematoma muscle
    Additional description: Haematoma muscle
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal infection
    Additional description: Staphylococcal infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
    Additional description: Peritonitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Febrile infection
    Additional description: Febrile infection
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
    Additional description: Clostridium difficile colitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
    Additional description: Malnutrition
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
    Additional description: Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Radiochemotherapy Folfirinox
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 42 (97.62%)
    41 / 41 (100.00%)
    Vascular disorders
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    9 / 42 (21.43%)
    2 / 41 (4.88%)
         occurrences all number
    14
    2
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    4 / 42 (9.52%)
    7 / 41 (17.07%)
         occurrences all number
    4
    10
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    4 / 42 (9.52%)
    5 / 41 (12.20%)
         occurrences all number
    4
    6
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 41 (9.76%)
         occurrences all number
    2
    5
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    2 / 42 (4.76%)
    4 / 41 (9.76%)
         occurrences all number
    2
    4
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    22 / 42 (52.38%)
    17 / 41 (41.46%)
         occurrences all number
    38
    27
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Psychiatric disorders
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    0 / 42 (0.00%)
    4 / 41 (9.76%)
         occurrences all number
    0
    4
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    2 / 42 (4.76%)
    4 / 41 (9.76%)
         occurrences all number
    2
    14
    Investigations
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 41 (2.44%)
         occurrences all number
    5
    3
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Nervous system disorders
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    2 / 42 (4.76%)
    7 / 41 (17.07%)
         occurrences all number
    2
    7
    Headache
    Additional description: Headache
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    9 / 42 (21.43%)
    4 / 41 (9.76%)
         occurrences all number
    9
    5
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    17 / 42 (40.48%)
    26 / 41 (63.41%)
         occurrences all number
    25
    38
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    15 / 42 (35.71%)
    16 / 41 (39.02%)
         occurrences all number
    22
    20
    Lymphopenia
    Additional description: Lymphopenia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 41 (4.88%)
         occurrences all number
    4
    4
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    8 / 42 (19.05%)
    5 / 41 (12.20%)
         occurrences all number
    17
    8
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    10 / 42 (23.81%)
    9 / 41 (21.95%)
         occurrences all number
    19
    14
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    7 / 42 (16.67%)
    9 / 41 (21.95%)
         occurrences all number
    21
    16
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    6 / 42 (14.29%)
    2 / 41 (4.88%)
         occurrences all number
    6
    3
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    33 / 42 (78.57%)
    28 / 41 (68.29%)
         occurrences all number
    62
    59
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    9 / 42 (21.43%)
    9 / 41 (21.95%)
         occurrences all number
    15
    12
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    10 / 42 (23.81%)
    9 / 41 (21.95%)
         occurrences all number
    10
    13
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 41 (4.88%)
         occurrences all number
    7
    2
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    7 / 42 (16.67%)
    0 / 41 (0.00%)
         occurrences all number
    7
    0
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    4
    3
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    14 / 42 (33.33%)
    8 / 41 (19.51%)
         occurrences all number
    26
    17
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 41 (9.76%)
         occurrences all number
    3
    6
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    32 / 42 (76.19%)
    24 / 41 (58.54%)
         occurrences all number
    66
    45
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Rash
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    4
    0
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    4
    3
    Renal and urinary disorders
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 41 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    Infections and infestations
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    0 / 42 (0.00%)
    4 / 41 (9.76%)
         occurrences all number
    0
    5
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    4 / 42 (9.52%)
    7 / 41 (17.07%)
         occurrences all number
    4
    10
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Metabolism and nutrition disorders
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    6
    1
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    18 / 42 (42.86%)
    6 / 41 (14.63%)
         occurrences all number
    34
    11
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 41 (7.32%)
         occurrences all number
    5
    4
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    11 / 42 (26.19%)
    6 / 41 (14.63%)
         occurrences all number
    14
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2013
    protocol version 2.0: change of sponsor, change from monocentic to multicentric
    25 Aug 2016
    protocol version 3.0: update of background information (epidemiology of PDAC), inclusion of secondary objective, enrollment of up to a maximum sample size of 112 patients, update of estimated treatment duration, clarifications
    25 May 2021
    protocol version 4.0: update of estimated treatment duration, study treatments leucovorin 200 mg/m² added, COVID-19 related information, clarifications

    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.
    The study was planned for 112 patients. Due to the slow recruitment only 83 patients were randomized.
    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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