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    Clinical Trial Results:
    Metabolic and Molecular Response Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction (MeMoRI)

    Summary
    EudraCT number
    		 2014-000860-16
    Trial protocol
    		 DE  
    Global end of trial date
    07 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Aug 2021
    First version publication date
    25 Aug 2021
    Other versions
    Summary report(s)
    		 CSR_MeMoRI

    Trial information

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    Trial identification
    Sponsor protocol code
    MEM-0000-SIV-0028-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02287129
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München
    Sponsor organisation address
    Ismaninger Str. 22, Munich, Germany, 81675
    Public contact
    Prof. Dr. med. Jens Siveke, Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik, 0049 2017233704, Jens.Siveke@uk-essen.de
    Scientific contact
    Prof. Dr. med. Jens Siveke, Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik, 0049 2017233704, Jens.Siveke@uk-essen.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Neoadjuvant therapy optimization in metabolic PET-Non-responders (P-NR) for improved R0 resection rates in locally advanced AEG (R0 resection rate of patients suffering from metabolically (following PET criteria) chemotherapy-resistant, locally advanced AEG, who receive a more intensive neoadjuvant radio-chemotherapy (INRCT))
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 Standard of care. Concomitant medication and supportive therapy were carried out according to standard clinical guidelines and at the judgement of the investigators
    Evidence for comparator
    		 n.a.
    Actual start date of recruitment
    05 Dec 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    49
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted multicentric in Germany between 05.12.2014 (first Patient recruited) and 07.08.2020 (last patient completed).

    Pre-assignment
    Screening details
    		 Pre-screening processes were in place. The measures for tumor staging and for testing of functional operability follwos the standard Guidelines of the test centers. The Screening should take place 14 days before inclusion in the study.

    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
    This is a single arm, open label study

    Arms
    Arm title
    		 All patients
    Arm description
    		 single arm, therapeutic explorative phase II clinical multi-center trial
    Arm type
    		 All patients

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    ATC L01CD02; Substance Code SUB09583MIG
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 50 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    ATC-Code L01XA03, EV Substance code SUB09490MIG
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 130 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Epirubicinhydrochlorid
    Investigational medicinal product code
    ATC Code: L01 DB03
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 50 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    ATC Code: L01XA02, SUB06614MIG
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 2 mg/ml milligram(s)/millilitre

    Investigational medicinal product name
    Capecitabin
    Investigational medicinal product code
    ATC Code: L01BC06
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Per day: 1250 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    5-Fluorouracil
    Investigational medicinal product code
    ATC Code: L01BC02
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 200 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    ATC Code: L01XA01
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 80 mg/m2 milligram(s)/square meter

    Investigational medicinal product name
    Folinsäure,
    Investigational medicinal product code
    ATC Code: V03AF03
    Other name
    Folinic acid
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day: 200 mg/m2 milligram(s)/square meter

    Number of subjects in period 1
    		All patients
    Started
    75
    Completed
    33
    Not completed
    42
         Adverse event, serious fatal
    14
         Consent withdrawn by subject
    5
         Diverse
    13
         Lost to follow-up
    9
         Protocol deviation
    1

    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
    		 75 75
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 49 49
        From 65-84 years
    		 26 26
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 66 66
    Responder classification
    Patients are classified in responders (P-R) and non-responders (P-NR) according to RET assessment.
    Units: Subjects
        P-R
    		 50 50
        R-NR
    		 25 25
    Tumor size
    Units: Subjects
        Tx
    		 2 2
        T2
    		 8 8
        T3
    		 62 62
        T4
    		 3 3
    Lymph nodes involved
    Units: Subjects
        Nx
    		 48 48
        N0
    		 7 7
        N1
    		 17 17
        N2
    		 3 3
    Distant metastases
    Units: Subjects
        M0
    		 74 74
        M1
    		 1 1
    Grading
    Units: Subjects
        G1
    		 6 6
        G2
    		 32 32
        G3
    		 33 33
        Unknown
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Responder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PET responder

    Subject analysis set title
    Non-responder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PET non-responder

    Subject analysis sets values
    		 Responder Non-responder
    Number of subjects
    50
    25
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    34
    15
        From 65-84 years
    16
    10
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    6
    3
        Male
    44
    22
    Responder classification
    Patients are classified in responders (P-R) and non-responders (P-NR) according to RET assessment.
    Units: Subjects
        P-R
    50
    0
        R-NR
    0
    25
    Tumor size
    Units: Subjects
        Tx
    1
    1
        T2
    4
    4
        T3
    42
    20
        T4
    3
    0
    Lymph nodes involved
    Units: Subjects
        Nx
    34
    14
        N0
    4
    3
        N1
    11
    6
        N2
    1
    2
    Distant metastases
    Units: Subjects
        M0
    49
    25
        M1
    1
    0
    Grading
    Units: Subjects
        G1
    4
    2
        G2
    24
    8
        G3
    21
    12
        Unknown
    1
    3

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 single arm, therapeutic explorative phase II clinical multi-center trial

    Subject analysis set title
    Responder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PET responder

    Subject analysis set title
    Non-responder
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PET non-responder

    Primary: R0 in P-NR

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    End point title
    		 R0 in P-NR
    End point description
    R0 resection rate in PET non-responders that were treated according to the study protocol
    End point type
    Primary
    End point timeframe
    Measured after surgery
    End point values
    		 All patients Non-responder
    Number of subjects analysed
    22 [1]
    22 [2]
    Units: Subjects
        R0
    19
    19
        other
    3
    3
    Notes
    [1] - The per-protocol set of P-NR consisted of 22 patients.
    [2] - The per-protocol set of P-NR consisted of 22 patients.
    Statistical analysis title
    		 Compare R0 to 0.70
    Statistical analysis description
    Compare the R0 resection rate on the set of per-protocol treated P-NR patients to the pre-defined value of 0.70 using the one-sided exact binomial test.
    Comparison groups
    All patients v Non-responder
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.068 [4]
    Method
    		 Exact binomial test
    Parameter type
    		 rate
    Point estimate
    86.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 65.1
         upper limit
    		 97.1
    Notes
    [3] - Due to limitations of the EUDRACT database, it is not possible to enter comparative statistics using one study arm and a fixed value. This is why the patient number appears double. Only 22 patients were used to evaluate the primary endpoint.
    [4] - One-sided

    Secondary: Histological regression

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    End point title
    		 Histological regression
    End point description
    Histological grade defined by Becker Criteria measured on the per-protocol set
    End point type
    Secondary
    End point timeframe
    Measured between day 28 and 43 after radio-chemotherapy.
    End point values
    		 All patients Responder Non-responder
    Number of subjects analysed
    67 [5]
    45 [6]
    22 [7]
    Units: Subjects
        Grade 1
    26
    14
    12
        Grade 2
    24
    18
    6
        Grade 3
    17
    13
    4
    Notes
    [5] - The per-protocol set consisted of 67 patients.
    [6] - The per-protocol set of P-R consisted of 45 patients.
    [7] - The per-protocol set of P-NR consisted of 22 patients.
    No statistical analyses for this end point

    Secondary: Overal survival

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    End point title
    		 Overal survival
    End point description
    Kaplan-Meier estimates for the overal survival.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 All patients Responder Non-responder
    Number of subjects analysed
    67 [8]
    45 [9]
    22 [10]
    Units: months
        arithmetic mean (confidence interval 95%)
    80.3 (67.1 to 88.6)
    86.9 (71.2 to 94.4)
    66.2 (39.6 to 83.3)
    Notes
    [8] - The per-protocol set consisted of 67 patients.
    [9] - The per-protocol set of P-R consisted of 45 patients.
    [10] - The per-protocol set of P-NR consisted of 22 patients.
    No statistical analyses for this end point

    Secondary: Disease-free survival

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    End point title
    		 Disease-free survival
    End point description
    Kaplan-Meier estimate of the disease-free survival, defined as the period from start of study to earlier occuring event: death or relapse.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 All patients Responder Non-responder
    Number of subjects analysed
    67 [11]
    45 [12]
    22 [13]
    Units: Months
        arithmetic mean (confidence interval 95%)
    62.8 (49.0 to 73.8)
    64.5 (47.3 to 77.3)
    59.1 (34.5 to 77.1)
    Notes
    [11] - The per-protocol set consisted of 67 patients.
    [12] - The per-protocol set of P-R consisted of 45 patients.
    [13] - The per-protocol set of P-NR consisted of 22 patients.
    No statistical analyses for this end point

    Secondary: Quality of life at BL

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    End point title
    		 Quality of life at BL
    End point description
    EORTC-QLQC30
    End point type
    Secondary
    End point timeframe
    Measured at baseline
    End point values
    		 Responder Non-responder
    Number of subjects analysed
    45 [14]
    22 [15]
    Units: points
        arithmetic mean (standard deviation)
    80.7 ( 14.5 )
    88.6 ( 9.5 )
    Notes
    [14] - The per-protocol set of P-R consisted of 45 patients.
    [15] - The per-protocol set of P-NR consisted of 22 patients.
    No statistical analyses for this end point

    Secondary: Quality of life at 24 Months

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    End point title
    		 Quality of life at 24 Months
    End point description
    End point type
    Secondary
    End point timeframe
    Measured at 24 Months
    End point values
    		 Responder Non-responder
    Number of subjects analysed
    45 [16]
    22 [17]
    Units: points
        arithmetic mean (standard deviation)
    68.3 ( 21.9 )
    67.5 ( 15.7 )
    Notes
    [16] - The per-protocol set of P-R consisted of 45 patients.
    [17] - The per-protocol set of P-NR consisted of 22 patients.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Reporting of AEs / SAEs begins with the inclusion of the patient in the study and ends 3 months after the operation or after (premature) termination of the study participation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 single arm, therapeutic explorative phase II clinical multi-center trial

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 75 (21.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diaphragmatic abnormal relaxation
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Pulmonary embolism
         subjects affected / exposed
    3 / 75 (4.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Critical illness polyneuropathy
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    5 / 75 (6.67%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    gallbladder perforation
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal infarct
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    critical illness myopathy
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 75 (2.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 75 (1.33%)
         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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 75 (62.67%)
    Injury, poisoning and procedural complications
    Anastomotic complication
         subjects affected / exposed
    6 / 75 (8.00%)
         occurrences all number
    6
    Nervous system disorders
    Polyneuropathy
         subjects affected / exposed
    12 / 75 (16.00%)
         occurrences all number
    13
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    7 / 75 (9.33%)
         occurrences all number
    7
    Thrombocytopenia
         subjects affected / exposed
    4 / 75 (5.33%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 75 (5.33%)
         occurrences all number
    5
    Mucosal inflammation
         subjects affected / exposed
    4 / 75 (5.33%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 75 (9.33%)
         occurrences all number
    9
    Dysphagia
         subjects affected / exposed
    6 / 75 (8.00%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    11 / 75 (14.67%)
         occurrences all number
    13

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2014
    change of inclusion criteria to include elderly patients
    22 Sep 2015
    ÖGD and PET can be done on the same day; added routine medication (mFOLFOX); additional deputy coordinating investigator and PI
    02 Nov 2017
    prolongation of recruitment period; increase of sample size from 75 to 120; additional clinical trial site Köln Recruitment was preliminarily stopped 29.08.2018 due to emerging new routine therapeutic regimen expected to impact ratio PET-responder vs PET-non-responder and improve rate of complete remissions. Follow-up of already included patients was conducted as originally planned.

    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.
    While results are promising, significance could not be demonstrated. The response rate was higher than originally assumed due to the emergence of new standard therapy regimen during the course of the clinical trial (premature discontinuation).
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