age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
Item
Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1513040 (UMLS CUI 2011AA)
C0948380 (UMLS CUI 2011AA)
10052358 (MedDRA 14.1)
C1405978 (UMLS CUI 2011AA)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0596581 (UMLS CUI 2011AA)
C0796324 (UMLS CUI 2011AA)
C1710384 (UMLS CUI 2011AA)
10066377 (MedDRA 14.1)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C1537502 (UMLS CUI 2011AA)
C0678926 (UMLS CUI 2011AA)
C0995188 (UMLS CUI 2011AA)
409400001 (SNOMED CT 2011_0131)
C0879427 (UMLS CUI 2011AA)
424401006 (SNOMED CT 2011_0131)
No chemotherapy within 4 weeks before treatment start
Item
No chemotherapy within 4 weeks before treatment start
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C3173309 (UMLS CUI 2011AA)
413946009 (SNOMED CT 2011_0131)
No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
Item
No residual significant toxicity (> NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
C1513882 (UMLS CUI 2011AA)
C2826262 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
No previous treatment with experimental therapies after standard therapies is allowed.
Item
No previous treatment with experimental therapies after standard therapies is allowed.
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0949266 (UMLS CUI 2011AA)
Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
Item
Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
boolean
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
Item
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
boolean
C1520224 (UMLS CUI 2011AA)
WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3
Item
WBC >= 3,000/mm3, absolute neutrophil count (ANC) >= 1,500/mm3, platelet count >=100,000/mm3
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
Item
Bilirubin <= 2.0 mg/dL (40 micromol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be <=3.5 mg/dL (59.86 micromol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) <= 5 x upper limit of normal (ULN). Hepatic alkaline phosphatase <= 3.0 x ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
boolean
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0855470 (UMLS CUI 2011AA)
10005308 (MedDRA 14.1)
Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
Item
Serum creatinine <= 2.0 mg/dL (180 micromol/L)or creatinine clearance >= 50 ml/min. , proteinuria < 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
C0430371 (UMLS CUI 2011AA)
271346009 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
Item
Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
boolean
C0021430 (UMLS CUI 2011AA)
Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)
Item
Evidence of any other malignant disease (with the exception of tumors operatively cured >= 5 years prior to the trial)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C1880198 (UMLS CUI 2011AA)
Known brain metastases
Item
Brain metastases
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
Uncontrolled pleural effusions
Item
Uncontrolled pleural effusions
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0032227 (UMLS CUI 2011AA)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
Interstitial pneumonitis or pulmonary fibrosis
Item
Interstitial pneumonitis or pulmonary fibrosis
boolean
C0206061 (UMLS CUI 2011AA)
64667001 (SNOMED CT 2011_0131)
10022618 (MedDRA 14.1)
J84.9 (ICD-10-CM Version 2010)
C0034069 (UMLS CUI 2011AA)
51615001 (SNOMED CT 2011_0131)
10037383 (MedDRA 14.1)
J84.1 (ICD-10-CM Version 2010)
E13527 (CTCAE 1105E)
Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
Item
Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0683578 (UMLS CUI 2011AA)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0001973 (UMLS CUI 2011AA)
284591009 (SNOMED CT 2011_0131)
10001639 (MedDRA 14.1)
F10.2 (ICD-10-CM Version 2010)
305.01 (ICD-9-CM Version 2011)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
Unstable cardiac disease in the last 6 months
Item
Unstable cardiac disease in the last 6 months
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
Item
Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not > 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1166209 (UMLS CUI 2011AA)
CL414476 (UMLS CUI 2011AA)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C1708745 (UMLS CUI 2011AA)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
Item
Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C1880018 (UMLS CUI 2011AA)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
Item
Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
boolean
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0040046 (UMLS CUI 2011AA)
64156001 (SNOMED CT 2011_0131)
10043570 (MedDRA 14.1)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0150457 (UMLS CUI 2011AA)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
C0918269 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
History of hypersensitivity to mistletoe
Item
History of hypersensitivity to mistletoe
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0042785 (UMLS CUI 2011AA)
43601004 (SNOMED CT 2011_0131)
History of primary immunodeficiency
Item
History of primary immunodeficiency
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0398686 (UMLS CUI 2011AA)
58606001 (SNOMED CT 2011_0131)
10064859 (MedDRA 14.1)
Known human immunodeficiency virus (HIV) or known active viral hepatic infections
Item
Known human immunodeficiency virus (HIV) or known active viral hepatic infections
boolean
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
070 (ICD-9-CM Version 2011)
E11410 (CTCAE 1105E)
Prior treatment with CY-503
Item
Prior treatment with CY-503
boolean
C1514463 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
Item
A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0423895 (UMLS CUI 2011AA)
247571009 (SNOMED CT 2011_0131)
C0038580 (UMLS CUI 2011AA)
2403008 (SNOMED CT 2011_0131)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)