Adenocarcinoma Biliary tract | Neoplasms intrahepatic | Neoplasms Hilar | Carcinoma Involving Gallbladder
Item
1. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). carcinomas involving the gall bladder are allowed.
boolean
C0001418 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1512948 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0205150 (UMLS CUI [3,2])
C0007097 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0016976 (UMLS CUI [4,3])
Complete excision macroscopic
Item
2. macroscopically complete resection within 8 weeks before start of chemotherapy.
boolean
C0015250 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Informed Consent
Item
3. written informed consent.
boolean
C0021430 (UMLS CUI [1])
WHO performance status scale
Item
4. health status: who performance status (ps) 0-1
boolean
C1298650 (UMLS CUI [1])
Age
Item
5. age >18 years
boolean
C0001779 (UMLS CUI [1])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of cockcroft-gault)
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement
Item
7. adequate hepatic function (bilirubin ≤ 3 x lun, ap ≤ 5 x lun, asat ≤ 5 x lun)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Hematologic function | Neutrophil count | Platelet Count measurement
Item
8. adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb
boolean
C0221130 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement
Item
≥ 9,5 mg/dl
boolean
C0518015 (UMLS CUI [1])
Compliance behavior allowing TNM clinical staging | Proximity Geographic allowing TNM clinical staging | Compliance behavior allowing Therapeutic procedure | Proximity Geographic allowing Therapeutic procedure | Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up
Item
9. patient compliance and geographic proximity allowing proper staging, treatment and follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1514583 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C1321605 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1514583 (UMLS CUI [4,1])
C1517526 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
C1321605 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C1514583 (UMLS CUI [6,1])
C1517526 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C3274571 (UMLS CUI [6,4])
Gender Breast Feeding Absent | Gender Sexually active Contraceptive methods | Pregnancy Absent | Planned Pregnancy Unwilling | Gender Age Pregnancy test negative | Gender Reproduction Unwilling
Item
10. women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. a negative pregnancy test before inclusion into the trial is required for women < 50 years. men who agree not to father a child during participation in the trial or during the 12 months thereafter.
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032992 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0001779 (UMLS CUI [5,2])
C0427780 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0035150 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
1. pregnancy or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Treated
Item
2. previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, hb < 9,5 mg/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
4. bilirubin > 3 x lun, alat > 5 x lun, asat > 5 x lun
boolean
C0741494 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. creatinine clearance < 60 ml/min, calculated according to the formula of cockcroft-gault
boolean
C2711451 (UMLS CUI [1])
Prior Chemotherapy | gemcitabine
Item
6. prior chemotherapy with gemcitabine
boolean
C1514457 (UMLS CUI [1])
C0045093 (UMLS CUI [2])
Cardiovascular Disease Severe | Cardiovascular Disease Uncontrolled | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia
Item
7. severe or uncontrolled cardiovascular disease (congestive heart failure nyha iii or iv, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
Mental disorders Exclude Comprehension Study Protocol | Mental disorders Exclude Informed Consent
Item
8. psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Communicable Disease Uncontrolled
Item
9. active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
10. preexisting peripheral neuropathy (> grade 1)
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Comorbidity Serious Study Subject Participation Status Impaired | Diabetic - poor control | Autoimmune Diseases
Item
11. serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0421258 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
Investigational New Drugs | Cancer treatment | Study Subject Participation Status
Item
12. concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
boolean
C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs
Item
13. known hypersensitivity to the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])