ID

16812

Description

Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00156975

Link

https://clinicaltrials.gov/show/NCT00156975

Keywords

Versions (2)
  1. 8/8/16 8/8/16 -
  2. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00156975

English

Eligibility Colorectal Neoplasms NCT00156975

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients after r0-resection of colorectal liver metastases
Description

Colorectal Carcinoma Excision | Secondary malignant neoplasm of liver Excision | Residual tumor stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0728940
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C0728940
UMLS CUI [3]
C0475286
age: >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky-index >= 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
adequate contraception for male and female patients
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
oral and written informed consent (gcp)
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Skin carcinoma Treated | Malignant Neoplasm Free Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0332296
UMLS CUI [4,3]
C1265611
other participation in clinical trials within 30 days before randomization
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)
Description

Prior Chemotherapy | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0085533
creatinine clearance <50 ml/min
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
hepatic insufficiency (alat, asat, bilirubin, ap >5 x upper limit)
Description

Hepatic Insufficiency | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Alkaline Phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0002059
peripheral neuropathy > ctc grade 1
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
uncontrolled cardiac insufficiency or angina pectoris
Description

Heart failure Uncontrolled | Angina Pectoris Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
active infections
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
severe neurological or psychiatric illness
Description

nervous system disorder Severe | Mental disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
breast-feeding or pregnant women
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
incapacity to take part in regular visits
Description

Patient Visit Regular participation Impairment

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0221099
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Similar models

Eligibility Colorectal Neoplasms NCT00156975

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Excision | Secondary malignant neoplasm of liver Excision | Residual tumor stage
Item
patients after r0-resection of colorectal liver metastases
boolean
C0009402 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0494165 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0475286 (UMLS CUI [3])
Age
Item
age: >= 18 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky-index >= 70%
boolean
C0206065 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophiles >1,5 x10e9/l, thrombocytes 100 x10e9/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Gender Contraceptive methods
Item
adequate contraception for male and female patients
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed consent
Item
oral and written informed consent (gcp)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Skin carcinoma Treated | Malignant Neoplasm Free Quantity
Item
other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0332296 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Study Subject Participation Status
Item
other participation in clinical trials within 30 days before randomization
boolean
C2348568 (UMLS CUI [1])
Prior Chemotherapy | Chemotherapy, Adjuvant
Item
previous chemotherapy (except adjuvant chemotherapy with an interval of >= 6 months)
boolean
C1514457 (UMLS CUI [1])
C0085533 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance <50 ml/min
boolean
C0373595 (UMLS CUI [1])
Hepatic Insufficiency | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Alkaline Phosphatase
Item
hepatic insufficiency (alat, asat, bilirubin, ap >5 x upper limit)
boolean
C1306571 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0002059 (UMLS CUI [5])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy > ctc grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Heart failure Uncontrolled | Angina Pectoris Uncontrolled
Item
uncontrolled cardiac insufficiency or angina pectoris
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Communicable Diseases
Item
active infections
boolean
C0009450 (UMLS CUI [1])
nervous system disorder Severe | Mental disorder Severe
Item
severe neurological or psychiatric illness
boolean
C0027765 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Breast Feeding | Pregnancy
Item
breast-feeding or pregnant women
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Patient Visit Regular participation Impairment
Item
incapacity to take part in regular visits
boolean
C1512346 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
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