Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
histologically verified adenocarcinoma in colon or rectum with metastatic spread.
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
KRAS Gene Mutation Absent
Item
no mutations in the kras gene.
boolean
C1517649 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Fluorouracil Resistant | Oxaliplatin Resistant | Irinotecan Resistant
Item
resistance to 5-fu, oxaliplatin and irinotecan.
boolean
C0016360 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0069717 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C0123931 (UMLS CUI [3,1])
C0332325 (UMLS CUI [3,2])
Age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
ps 0-2.
boolean
C1518965 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to recist criteria.
boolean
C1513041 (UMLS CUI [1])
Hematology | Neutrophil count | White Blood Cell Count procedure | Platelet Count measurement
Item
haematology: neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes
boolean
C0200627 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Bilirubinemia
Item
≥100 and bilirubinaemia ≤3 x upper normal value. samples no more than 4 weeks old.
boolean
C0020433 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Availability of Blood specimen | Availability of Tissue specimen | Evaluation Biological Markers
Item
acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
boolean
C0470187 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C0005516 (UMLS CUI [3,2])
Informed Consent
Item
oral and written informed consent.
boolean
C0021430 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
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])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
CNS metastases | CNS metastases Suspected
Item
verified or clinically suspected cns metastasis.
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Therapy, Investigational
Item
other experimental treatment.
boolean
C0949266 (UMLS CUI [1])
Disease Serious
Item
serious medical disease according to investigator's judgement.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Adjuvants Quantity
Item
hypersensitivity to the active substance or to one or more of the auxiliary substances.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001552 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Pneumonia, Interstitial | Pulmonary Fibrosis
Item
patients with interstitial pneumonitis or pulmonary fibrosis.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])