Prior chemotherapy
Item
Patient didn't have prior chemotherapy for cholangiocarcinoma
boolean
C1514457 (UMLS CUI [1,1])
C0206698 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Other malignant neoplasia
Item
Patient had no previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
boolean
C0205394 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0332300 (UMLS CUI [3,1])
C1518408 (UMLS CUI [3,2])
C0007114 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Cardiovascular disease
Item
Patient has no 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 arrhythmia)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0002965 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1275835 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0003811 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Psychiatric disorders
Item
Patient has no psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0582778 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Medical conditions
Item
Patient has no serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Contraception
Item
Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception
boolean
C0700589 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Pregnancy
Item
Patient is not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Diagnosis
Item
Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangicarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (hcc/cca) are excluded)
boolean
C0001418 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0679557 (UMLS CUI [1,3])
C0279651 (UMLS CUI [1,4])
C0205281 (UMLS CUI [1,5])
C0015250 (UMLS CUI [2,1])
C1551402 (UMLS CUI [2,2])
Age
Item
Patient aged >18 years
boolean
C0001779 (UMLS CUI [1])
Complete resection of tumor
Item
Patient has gotten macroscopically complete resection (r0/1) within 6 (-16) weeks before scheduled start of chemotherapy
boolean
C0006826 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Impairment of quality of life
Item
Patient has an ECOG between 0-1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
Patient with an adequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Liver function
Item
Patient with an adequate liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Renal function
Item
Patient with an adequate renal function
boolean
C0232804 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Infection
Item
Patient has no active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
boolean
C3714514 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0042721 (UMLS CUI [2,2])
C0280274 (UMLS CUI [2,3])
Other treatments
Item
Patient has no concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
boolean
C0304229 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Pregnancy
Item
Patient has a negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause
boolean
C0427780 (UMLS CUI [1])