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ID

45880

Description

CombiCaRe Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Keywords

Versions (1)
  1. 11/10/23 11/10/23 - Nelly Zental
Copyright Holder

Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Uploaded on

November 10, 2023

DOI

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License

Creative Commons BY 4.0
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    CombiCaRe study

    English

    Screening

    12 forms  
    1. StudyEvent: combicare trial
      1. Screening
      2. Intervention
      3. POD 3
      4. POD 7
      5. POD 14 / Discharge
      6. POD 30
      7. POD 60/Discontinuation
      8. Signature
    2. StudyEvent: Readmission To Hospital
      1. Readmission To Hospital
    3. StudyEvent: Adverse Events
      1. Adverse Events
    4. StudyEvent: Concomitant Medication
      1. Concomitant Medication
    5. StudyEvent: Protocol Violation
      1. Protocol violation
    Record ID
    Description

    Record ID

    Alias
    UMLS CUI [1,1]
    C1830337
    Record ID
    Description

    Record ID

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    Screening
    Description

    Screening

    Alias
    UMLS CUI [1,1]
    C1710477
    Screening No.
    Description

    Screening No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    PatID
    Description

    PatID

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1269815
    Date of first screening visit (day of consultation)
    Description

    Date of first screening visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C4019187
    UMLS CUI [1,2]
    C0009818
    Date of second screening visit (start of hospital admission)
    Description

    Date of second screening visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0205436
    UMLS CUI [1,2]
    C1320303
    UMLS CUI [1,3]
    C0184666
    Informed consent
    Description

    Informed consent

    Alias
    UMLS CUI [1,1]
    C0021430
    Informed consent signed
    Description

    consent signed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0742766
    Date of informed consent
    Description

    Date of consent

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2985782
    Inclusion criteria
    Description

    Inclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    Newly diagnosed, resectable or borderline resectable pancreatic cancer located in the head of the pancreas, without arterial involvement, on cross-sectional imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
    Description

    new pancreatic head cancer, no arterial involvement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4763560
    UMLS CUI [1,2]
    C0854778
    UMLS CUI [1,3]
    C1518321
    UMLS CUI [1,4]
    C0153458
    Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)
    Description

    Histology / cytology pancreatic ductal adenoca

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1335302
    UMLS CUI [1,2]
    C0456369
    UMLS CUI [1,3]
    C0497098
    >=18 and <=75 years of age
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C0001675
    Capacity to consent
    Description

    Capacity to consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1516240
    UMLS CUI [1,2]
    C0021430
    Written informed consent
    Description

    Written informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    Description

    ECOG 0-2

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1520224
    Patient considered to tolerate surgery and chemotherapy by a multidisciplinary team
    Description

    Toleration of surgery and chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,3]
    C4053931
    Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Childbearing potential is defined according to the "Recommendations related to contraception and pregnancy testing in clinical trials" of the Clinical Trial Facilitation Group (CTFG).
    Description

    adequate contraception

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4324275
    UMLS CUI [1,2]
    C0086582
    UMLS CUI [1,3]
    C1171186
    UMLS CUI [1,4]
    C5421123
    UMLS CUI [1,5]
    C5418626
    Exclusion criteria
    Description

    Exclusion criteria

    Alias
    UMLS CUI [1,1]
    C0680251
    Distant metastatic disease
    Description

    Distant metastatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5667514
    UMLS CUI [1,2]
    C2939420
    Renal disease, creatinine clearance < 50 ml/min (estimated by Cockroft-Gault)
    Description

    Renal disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022658
    UMLS CUI [1,2]
    C2711451
    Abnormal hepatic function as defined by a total bilirubine level >1.5 x the upper limit of normal (ULN), unless the patient has extrahepatic cholestasis due to pancreatic cancer, or alanine aminotransferase (ALT) >2.5 x ULN, liver cirrhosis (of any Child-Pugh grade)
    Description

    Abnormal hepatic function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086565
    UMLS CUI [1,2]
    C0311468
    UMLS CUI [1,3]
    C4478307
    UMLS CUI [1,4]
    C0023890
    UMLS CUI [1,5]
    C0005398
    Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
    Description

    Serious cardiovascular disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    Severe COPD, GOLD stage > II
    Description

    Severe COPD

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0205082
    American Society of Anesthesiologists (ASA) score >III
    Description

    ASA score

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4061000
    Active infection, including cholangitis
    Description

    Active infection, including cholangitis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3714514
    UMLS CUI [1,2]
    C0267917
    Abnormal bone marrow function, defined as an absolute white blood cell count <3/nl or platelet count <100/nl
    Description

    Abnormal bone marrow function

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1389329
    UMLS CUI [1,2]
    C0750394
    UMLS CUI [1,3]
    C0392386
    Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient
    Description

    Megaloblastic anemias

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002892
    UMLS CUI [1,2]
    C0002888
    UMLS CUI [1,3]
    C2004521
    Immunosuppressive therapy
    Description

    Immunosuppressive therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021079
    Allergy or known intolerance to 5-FU or calcium folinate
    Description

    Allergy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1744706
    UMLS CUI [1,2]
    C0013182
    Patients with a known lack of dihydropyrimidine-dehydrogenase (DPD)-activity or patients treated with DPD inhibitors such as brivudine
    Description

    Known lack of DPD-activity or DPD inhibitors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1959620
    UMLS CUI [1,2]
    C1511962
    Current pregnancy or breastfeeding (each pregnancy that occurs within 6 months after the termination of the perioperative chemotherapy has to be reported)
    Description

    Current pregnancy or breastfeeding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    History of another malignancy in the past 5 years
    Description

    Other malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C5452979
    UMLS CUI [1,3]
    C0262926
    Inability to comply with study and/or follow-up procedures
    Description

    Inability to comply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0582786
    (Language) problems in understanding the patient information document explaining the present clinical trial
    Description

    Problems in understanding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4693308
    UMLS CUI [1,2]
    C1955348
    Concurrent participation in another clinical study
    Description

    Concurrent participation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205420
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0008976
    Any condition which could result in an undue risk for the patient in the opinion of the investigator
    Description

    Undue risk

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035647
    Multidisciplinary tumor board
    Description

    Multidisciplinary tumor board

    Alias
    UMLS CUI [1,1]
    C5703153
    UMLS CUI [1,2]
    C4300109
    Date of multidisciplinary tumor board
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    Demographic data
    Description

    Demographic data

    Alias
    UMLS CUI [1,1]
    C4684639
    Age
    Description

    Age

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1,1]
    C0001779
    years
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0079399
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1,1]
    C0005910
    kg
    Pregnancy test
    Description

    Pregnancy test

    Alias
    UMLS CUI [1,1]
    C0032976
    Person of childbearing potential
    Description

    Childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    Result of pregnancy test
    Description

    Pregnancy Test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0427777
    Translational Studies
    Description

    Translational Studies

    Alias
    UMLS CUI [1,1]
    C1519620
    Blood sample taken (peripheral vein)
    Description

    Blood sample

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5401001
    Date blood sample taken
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1277698
    Baseline clinical data
    Description

    Baseline clinical data

    Alias
    UMLS CUI [1,1]
    C1442488
    UMLS CUI [1,2]
    C1516606
    Kind of pancreatic cancer (based on cross-sectional imaging)
    Description

    Kind of pancreatic cancer

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1880022
    UMLS CUI [1,2]
    C0030297
    UMLS CUI [1,3]
    C3824793
    ASA category (according to anesthesiologist's protocol)
    Description

    ASA

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1531480
    ECOG performance status
    Description

    ECOG

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1520224
    Relevant comorbidities
    Description

    Relevant comorbidities

    Alias
    UMLS CUI [1,1]
    C0009488
    Cardiovascular
    Description

    Cardiovascular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    Pulmonary
    Description

    Pulmonary

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024115
    Renal
    Description

    Renal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022658
    Hepatic
    Description

    Hepatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023895
    Autoimmune
    Description

    Autoimmune

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    Infectious
    Description

    Infectious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    Endocrine
    Description

    Endocrine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0014130
    Hematologic
    Description

    Hematologic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018939
    Smoker
    Description

    Smoker

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519386
    Other malignancies
    Description

    Other malignancies

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1869086
    History of other malignancies
    Description

    History of other malignancies

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    If yes, please specify
    Description

    specify malignancies

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Year of diagnosis (of the last malignancy)
    Description

    Year of diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C5667275
    Previous radiotherapy
    Description

    Previous radiotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0279134
    If yes, please specify region (tissue/organ)
    Description

    specify region

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Start of radiotherapy (month)
    Description

    Month radiotherapy start

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0439231
    Start of radiotherapy (year)
    Description

    Year radiotherapy start

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0439234
    End of radiotherapy (month)
    Description

    Month radiotherapy end

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0439231
    End of radiotherapy (year)
    Description

    Year radiotherapy end

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0439234
    Previous chemotherapy
    Description

    Previous chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    If yes, please specify chemotherapy regime
    Description

    specify regime

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    Start of chemotherapy (month)
    Description

    Month chemotherapy start

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,3]
    C0439231
    Start of chemotherapy (year)
    Description

    Year chemotherapy start

    Data type

    integer

    Alias
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,3]
    C0439234
    End of chemotherapy (month)
    Description

    Month chemotherapy end

    Data type

    text

    Alias
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [1,3]
    C0439231
    UMLS CUI [1,1]
    C0806020
    End of chemotherapy (year)
    Description

    Year chemotherapy end

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0806020
    UMLS CUI [1,3]
    C0439234
    Previous abdominal surgery
    Description

    Previous abdominal surgery

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0198482
    Previous abdominal surgery
    Description

    Previous abdominal surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C0198482
    appendectomy
    Description

    appendectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003611
    cholecystectomy
    Description

    cholecystectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008320
    incisional hernia repair
    Description

    incisional hernia repair

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0342971
    inguinal hernia repair
    Description

    inguinal hernia repair

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021446
    umbilical hernia repair
    Description

    umbilical hernia repair

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019333
    colon resection
    Description

    colon resection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4763870
    proctologic surgery
    Description

    proctologic surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033248
    UMLS CUI [1,2]
    C0543467
    small bowel surgery
    Description

    small bowel surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0192571
    gastric surgery
    Description

    gastric surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0192398
    hepatic surgery
    Description

    hepatic surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0193373
    biliary surgery
    Description

    biliary surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005427
    pancreatic surgery
    Description

    pancreatic surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2033062
    splenectomy
    Description

    splenectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037995
    renal surgery
    Description

    renal surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0194053
    hysterectomy
    Description

    hysterectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020699
    ovarectomy
    Description

    ovarectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0029936
    C-section
    Description

    C-section

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007876
    prostate surgery
    Description

    prostate surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0194790
    splenectomy
    Description

    splenectomy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037995
    other
    Description

    other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    If other, please specify
    Description

    specify other

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1521902
    Year of last surgery
    Description

    Year of last surgery

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439234
    Type of last surgery
    Description

    Type of last surgery

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0455713
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI [1,1]
    C2347852
    Any Concomitant Medication intake (especially coagulation)?
    Description

    Concomitant Medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2826666
    If yes, please fill out eForm 'Concomitant Medication'
    Description

    If yes, please fill out eForm 'Concomitant Medication'

    Alias
    UMLS CUI [1,1]
    C3273494
    Back to the top of the page

    Similar models

    Screening

    12 forms
    1. StudyEvent: combicare trial
      1. Screening
      2. Intervention
      3. POD 3
      4. POD 7
      5. POD 14 / Discharge
      6. POD 30
      7. POD 60/Discontinuation
      8. Signature
    2. StudyEvent: Readmission To Hospital
      1. Readmission To Hospital
    3. StudyEvent: Adverse Events
      1. Adverse Events
    4. StudyEvent: Concomitant Medication
      1. Concomitant Medication
    5. StudyEvent: Protocol Violation
      1. Protocol violation
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Record ID
    C1830337 (UMLS CUI [1,1])
    Record ID
    Item
    Record ID
    integer
    C0600091 (UMLS CUI [1,1])
    Item Group
    Screening
    C1710477 (UMLS CUI [1,1])
    Screening No.
    Item
    Screening No.
    integer
    C0600091 (UMLS CUI [1,1])
    PatID
    Item
    PatID
    integer
    C1269815 (UMLS CUI [1,1])
    Date of first screening visit
    Item
    Date of first screening visit (day of consultation)
    date
    C4019187 (UMLS CUI [1,1])
    C0009818 (UMLS CUI [1,2])
    Date of second screening visit
    Item
    Date of second screening visit (start of hospital admission)
    date
    C0205436 (UMLS CUI [1,1])
    C1320303 (UMLS CUI [1,2])
    C0184666 (UMLS CUI [1,3])
    Item Group
    Informed consent
    C0021430 (UMLS CUI [1,1])
    consent signed
    Item
    Informed consent signed
    boolean
    C0742766 (UMLS CUI [1,1])
    Date of consent
    Item
    Date of informed consent
    date
    C2985782 (UMLS CUI [1,1])
    Item Group
    Inclusion criteria
    C1512693 (UMLS CUI [1,1])
    new pancreatic head cancer, no arterial involvement
    Item
    Newly diagnosed, resectable or borderline resectable pancreatic cancer located in the head of the pancreas, without arterial involvement, on cross-sectional imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
    boolean
    C4763560 (UMLS CUI [1,1])
    C0854778 (UMLS CUI [1,2])
    C1518321 (UMLS CUI [1,3])
    C0153458 (UMLS CUI [1,4])
    Histology / cytology pancreatic ductal adenoca
    Item
    Histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants)
    boolean
    C1335302 (UMLS CUI [1,1])
    C0456369 (UMLS CUI [1,2])
    C0497098 (UMLS CUI [1,3])
    age
    Item
    >=18 and <=75 years of age
    boolean
    C0001779 (UMLS CUI [1,1])
    C0001675 (UMLS CUI [1,2])
    Capacity to consent
    Item
    Capacity to consent
    boolean
    C1516240 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    Written informed consent
    Item
    Written informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    ECOG 0-2
    Item
    Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1,1])
    Toleration of surgery and chemotherapy
    Item
    Patient considered to tolerate surgery and chemotherapy by a multidisciplinary team
    boolean
    C0543467 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C4053931 (UMLS CUI [1,3])
    adequate contraception
    Item
    Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Childbearing potential is defined according to the "Recommendations related to contraception and pregnancy testing in clinical trials" of the Clinical Trial Facilitation Group (CTFG).
    boolean
    C4324275 (UMLS CUI [1,1])
    C0086582 (UMLS CUI [1,2])
    C1171186 (UMLS CUI [1,3])
    C5421123 (UMLS CUI [1,4])
    C5418626 (UMLS CUI [1,5])
    Item Group
    Exclusion criteria
    C0680251 (UMLS CUI [1,1])
    Distant metastatic disease
    Item
    Distant metastatic disease
    boolean
    C5667514 (UMLS CUI [1,1])
    C2939420 (UMLS CUI [1,2])
    Renal disease
    Item
    Renal disease, creatinine clearance < 50 ml/min (estimated by Cockroft-Gault)
    boolean
    C0022658 (UMLS CUI [1,1])
    C2711451 (UMLS CUI [1,2])
    Abnormal hepatic function
    Item
    Abnormal hepatic function as defined by a total bilirubine level >1.5 x the upper limit of normal (ULN), unless the patient has extrahepatic cholestasis due to pancreatic cancer, or alanine aminotransferase (ALT) >2.5 x ULN, liver cirrhosis (of any Child-Pugh grade)
    boolean
    C0086565 (UMLS CUI [1,1])
    C0311468 (UMLS CUI [1,2])
    C4478307 (UMLS CUI [1,3])
    C0023890 (UMLS CUI [1,4])
    C0005398 (UMLS CUI [1,5])
    Serious cardiovascular disease
    Item
    Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
    boolean
    C0007222 (UMLS CUI [1,1])
    Severe COPD
    Item
    Severe COPD, GOLD stage > II
    boolean
    C0024117 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    ASA score
    Item
    American Society of Anesthesiologists (ASA) score >III
    boolean
    C4061000 (UMLS CUI [1,1])
    Active infection, including cholangitis
    Item
    Active infection, including cholangitis
    boolean
    C3714514 (UMLS CUI [1,1])
    C0267917 (UMLS CUI [1,2])
    Abnormal bone marrow function
    Item
    Abnormal bone marrow function, defined as an absolute white blood cell count <3/nl or platelet count <100/nl
    boolean
    C1389329 (UMLS CUI [1,1])
    C0750394 (UMLS CUI [1,2])
    C0392386 (UMLS CUI [1,3])
    Megaloblastic anemias
    Item
    Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient
    boolean
    C0002892 (UMLS CUI [1,1])
    C0002888 (UMLS CUI [1,2])
    C2004521 (UMLS CUI [1,3])
    Immunosuppressive therapy
    Item
    Immunosuppressive therapy
    boolean
    C0021079 (UMLS CUI [1,1])
    Allergy
    Item
    Allergy or known intolerance to 5-FU or calcium folinate
    boolean
    C1744706 (UMLS CUI [1,1])
    C0013182 (UMLS CUI [1,2])
    Known lack of DPD-activity or DPD inhibitors
    Item
    Patients with a known lack of dihydropyrimidine-dehydrogenase (DPD)-activity or patients treated with DPD inhibitors such as brivudine
    boolean
    C1959620 (UMLS CUI [1,1])
    C1511962 (UMLS CUI [1,2])
    Current pregnancy or breastfeeding
    Item
    Current pregnancy or breastfeeding (each pregnancy that occurs within 6 months after the termination of the perioperative chemotherapy has to be reported)
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    Other malignancy
    Item
    History of another malignancy in the past 5 years
    boolean
    C0006826 (UMLS CUI [1,1])
    C5452979 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    Inability to comply
    Item
    Inability to comply with study and/or follow-up procedures
    boolean
    C0582786 (UMLS CUI [1,1])
    Problems in understanding
    Item
    (Language) problems in understanding the patient information document explaining the present clinical trial
    boolean
    C4693308 (UMLS CUI [1,1])
    C1955348 (UMLS CUI [1,2])
    Concurrent participation
    Item
    Concurrent participation in another clinical study
    boolean
    C0205420 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Undue risk
    Item
    Any condition which could result in an undue risk for the patient in the opinion of the investigator
    boolean
    C0035647 (UMLS CUI [1,1])
    Item Group
    Multidisciplinary tumor board
    C5703153 (UMLS CUI [1,1])
    C4300109 (UMLS CUI [1,2])
    Date
    Item
    Date of multidisciplinary tumor board
    date
    C0011008 (UMLS CUI [1,1])
    Item Group
    Demographic data
    C4684639 (UMLS CUI [1,1])
    Age
    Item
    Age
    integer
    C0001779 (UMLS CUI [1,1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1,1])
    CL.1
    Code List
    Gender
    CL Item
    male (1)
    C0086582 (UMLS CUI [1,1])
    CL Item
    female (2)
    C0086287 (UMLS CUI [1,1])
    CL Item
    other (3)
    C0205394 (UMLS CUI [1,1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1,1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1,1])
    Item Group
    Pregnancy test
    C0032976 (UMLS CUI [1,1])
    Childbearing potential
    Item
    Person of childbearing potential
    boolean
    C3831118 (UMLS CUI [1,1])
    Item
    Result of pregnancy test
    text
    C0427777 (UMLS CUI [1,1])
    CL.2
    Code List
    Result of pregnancy test
    CL Item
    negative (1)
    C0205160 (UMLS CUI [1,1])
    CL Item
    positive (2)
    C1446409 (UMLS CUI [1,1])
    Item Group
    Translational Studies
    C1519620 (UMLS CUI [1,1])
    Blood sample
    Item
    Blood sample taken (peripheral vein)
    boolean
    C5401001 (UMLS CUI [1,1])
    Date
    Item
    Date blood sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C1277698 (UMLS CUI [1,2])
    Item Group
    Baseline clinical data
    C1442488 (UMLS CUI [1,1])
    C1516606 (UMLS CUI [1,2])
    Item
    Kind of pancreatic cancer (based on cross-sectional imaging)
    text
    C1880022 (UMLS CUI [1,1])
    C0030297 (UMLS CUI [1,2])
    C3824793 (UMLS CUI [1,3])
    CL.3
    Code List
    Kind of pancreatic cancer (based on cross-sectional imaging)
    CL Item
    resectable pancreatic cancer (1)
    C0854778 (UMLS CUI [1,1])
    CL Item
    borderline resectable cancer (2)
    C4763560 (UMLS CUI [1,1])
    Item
    ASA category (according to anesthesiologist's protocol)
    text
    C1531480 (UMLS CUI [1,1])
    CL.4
    Code List
    ASA category (according to anesthesiologist's protocol)
    CL Item
    i (1)
    CL Item
    ii (2)
    CL Item
    iii (3)
    CL Item
    iv (4)
    Item
    ECOG performance status
    text
    C1520224 (UMLS CUI [1,1])
    CL.5
    Code List
    ECOG performance status
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    Item Group
    Relevant comorbidities
    C0009488 (UMLS CUI [1,1])
    Cardiovascular
    Item
    Cardiovascular
    boolean
    C0007222 (UMLS CUI [1,1])
    Pulmonary
    Item
    Pulmonary
    boolean
    C0024115 (UMLS CUI [1,1])
    Renal
    Item
    Renal
    boolean
    C0022658 (UMLS CUI [1,1])
    Hepatic
    Item
    Hepatic
    boolean
    C0023895 (UMLS CUI [1,1])
    Autoimmune
    Item
    Autoimmune
    boolean
    C0004364 (UMLS CUI [1,1])
    Infectious
    Item
    Infectious
    boolean
    C0009450 (UMLS CUI [1,1])
    Endocrine
    Item
    Endocrine
    boolean
    C0014130 (UMLS CUI [1,1])
    Hematologic
    Item
    Hematologic
    boolean
    C0018939 (UMLS CUI [1,1])
    Item
    Smoker
    text
    C1519386 (UMLS CUI [1,1])
    CL.6
    Code List
    Smoker
    CL Item
    active smoker (1)
    C3241966 (UMLS CUI [1,1])
    CL Item
    former smoker (2)
    C0337671 (UMLS CUI [1,1])
    CL Item
    non-smoker (3)
    C0337672 (UMLS CUI [1,1])
    Item Group
    Other malignancies
    C0205394 (UMLS CUI [1,1])
    C1869086 (UMLS CUI [1,2])
    History of other malignancies
    Item
    History of other malignancies
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    specify malignancies
    Item
    If yes, please specify
    text
    C1521902 (UMLS CUI [1,1])
    Year of diagnosis
    Item
    Year of diagnosis (of the last malignancy)
    integer
    C5667275 (UMLS CUI [1,1])
    Previous radiotherapy
    Item
    Previous radiotherapy
    boolean
    C0279134 (UMLS CUI [1,1])
    specify region
    Item
    If yes, please specify region (tissue/organ)
    text
    C1521902 (UMLS CUI [1,1])
    Item
    Start of radiotherapy (month)
    text
    C0808070 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0439231 (UMLS CUI [1,3])
    CL.7
    Code List
    Start of radiotherapy (month)
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    unknown (13)
    Year radiotherapy start
    Item
    Start of radiotherapy (year)
    integer
    C0808070 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0439234 (UMLS CUI [1,3])
    Item
    End of radiotherapy (month)
    text
    C0806020 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0439231 (UMLS CUI [1,3])
    CL.7
    Code List
    End of radiotherapy (month)
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    unknown (13)
    Year radiotherapy end
    Item
    End of radiotherapy (year)
    integer
    C0806020 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0439234 (UMLS CUI [1,3])
    Previous chemotherapy
    Item
    Previous chemotherapy
    boolean
    C1514457 (UMLS CUI [1,1])
    specify regime
    Item
    If yes, please specify chemotherapy regime
    text
    C1521902 (UMLS CUI [1,1])
    Item
    Start of chemotherapy (month)
    text
    C0808070 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C0439231 (UMLS CUI [1,3])
    CL.7
    Code List
    Start of chemotherapy (month)
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    unknown (13)
    Year chemotherapy start
    Item
    Start of chemotherapy (year)
    integer
    C0392920 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,3])
    Item
    End of chemotherapy (month)
    text
    C0392920 (UMLS CUI [1,2])
    C0439231 (UMLS CUI [1,3])
    C0806020 (UMLS CUI [1,1])
    CL.7
    Code List
    End of chemotherapy (month)
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    unknown (13)
    Year chemotherapy end
    Item
    End of chemotherapy (year)
    integer
    C0392920 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    C0439234 (UMLS CUI [1,3])
    Item Group
    Previous abdominal surgery
    C0262926 (UMLS CUI [1,1])
    C0198482 (UMLS CUI [1,2])
    Previous abdominal surgery
    Item
    Previous abdominal surgery
    boolean
    C0205156 (UMLS CUI [1,1])
    C0198482 (UMLS CUI [1,2])
    appendectomy
    Item
    appendectomy
    boolean
    C0003611 (UMLS CUI [1,1])
    cholecystectomy
    Item
    cholecystectomy
    boolean
    C0008320 (UMLS CUI [1,1])
    incisional hernia repair
    Item
    incisional hernia repair
    boolean
    C0342971 (UMLS CUI [1,1])
    inguinal hernia repair
    Item
    inguinal hernia repair
    boolean
    C0021446 (UMLS CUI [1,1])
    umbilical hernia repair
    Item
    umbilical hernia repair
    boolean
    C0019333 (UMLS CUI [1,1])
    colon resection
    Item
    colon resection
    boolean
    C4763870 (UMLS CUI [1,1])
    proctologic surgery
    Item
    proctologic surgery
    boolean
    C0033248 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    small bowel surgery
    Item
    small bowel surgery
    boolean
    C0192571 (UMLS CUI [1,1])
    gastric surgery
    Item
    gastric surgery
    boolean
    C0192398 (UMLS CUI [1,1])
    hepatic surgery
    Item
    hepatic surgery
    boolean
    C0193373 (UMLS CUI [1,1])
    biliary surgery
    Item
    biliary surgery
    boolean
    C0005427 (UMLS CUI [1,1])
    pancreatic surgery
    Item
    pancreatic surgery
    boolean
    C2033062 (UMLS CUI [1,1])
    splenectomy
    Item
    splenectomy
    boolean
    C0037995 (UMLS CUI [1,1])
    renal surgery
    Item
    renal surgery
    boolean
    C0194053 (UMLS CUI [1,1])
    hysterectomy
    Item
    hysterectomy
    boolean
    C0020699 (UMLS CUI [1,1])
    ovarectomy
    Item
    ovarectomy
    boolean
    C0029936 (UMLS CUI [1,1])
    C-section
    Item
    C-section
    boolean
    C0007876 (UMLS CUI [1,1])
    prostate surgery
    Item
    prostate surgery
    boolean
    C0194790 (UMLS CUI [1,1])
    splenectomy
    Item
    splenectomy
    boolean
    C0037995 (UMLS CUI [1,1])
    other
    Item
    other
    boolean
    C0205394 (UMLS CUI [1,1])
    specify other
    Item
    If other, please specify
    integer
    C0205394 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Year of last surgery
    Item
    Year of last surgery
    integer
    C0439234 (UMLS CUI [1,1])
    Item
    Type of last surgery
    text
    C0455713 (UMLS CUI [1,1])
    CL.9
    Code List
    Type of last surgery
    CL Item
    open (1)
    C0348025 (UMLS CUI [1,1])
    CL Item
    minimally invasive (2)
    C2711297 (UMLS CUI [1,1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI [1,1])
    Concomitant Medication
    Item
    Any Concomitant Medication intake (especially coagulation)?
    boolean
    C2826666 (UMLS CUI [1,1])
    Item Group
    If yes, please fill out eForm 'Concomitant Medication'
    C3273494 (UMLS CUI [1,1])
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