ID

40383

Beschrijving

Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02071069

Link

https://clinicaltrials.gov/show/NCT02071069

Trefwoorden

Versies (1)
  1. 16-04-20 16-04-20 -
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See clinicaltrials.gov

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16 april 2020

DOI

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Creative Commons BY 4.0
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Eligibility Incurable Colorectal Cancer NCT02071069

Engels

Eligibility Incurable Colorectal Cancer NCT02071069

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
Beschrijving

Age | Colorectal cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0948380
2. eastern cooperative oncology group performance status ≤2 and
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. life expectancy of >3 months were enrolled.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
4. all patients had to have at least one measurable lesion according to the response evaluation criteria in solid tumors (recist, version 1.1)
Beschrijving

Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
5. none was previous exposure to cetuximab or irinotecan .
Beschrijving

Absence Exposure to Cetuximab | Absence Exposure to Irinotecan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0995188
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0123931
6. patients had to have adequate haematological (absolute neutrophil count >1.5 × 109/l; platelet count >100 × 109/l; haemoglobin >9 g/dl), hepatic [total bilirubin <1.5 ×
Beschrijving

Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0232741
UMLS CUI [6]
C1278039
the upper limit of normal (uln); alanine aminotransferase and aspartate aminotransferase <2.5 × uln, or <5 × uln in the case of hepatic metastases or <10 ×
Beschrijving

| C0153690 Secondary malignant neoplasm of bone

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
UMLS CUI [4]
C0153690
uln in the case of osseous metastases; alkaline phosphatase <2.5 × uln, or <5 × uln or <10 × uln in the case of hepatic or osseous metastases, respectively] and renal function (creatinine clearance ≥60 ml/min)
Beschrijving

Alkaline phosphatase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of bone | Renal function | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0494165
UMLS CUI [3]
C0153690
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0373595
7. all ras were wildtype. -
Beschrijving

RAS Wild Type

Datatype

boolean

Alias
UMLS CUI [1]
C4331207
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breast-feeding women;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. clinically significant cardiac disease;
Beschrijving

Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
3. lack of physical integrity of the upper gastrointestinal tract;
Beschrijving

Upper gastrointestinal tract | Integrity Physical Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C1268997
UMLS CUI [2,1]
C1947912
UMLS CUI [2,2]
C0205485
UMLS CUI [2,3]
C0332268
4. history of other malignancy;
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
5. central nervous system metastases. -
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
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Similar models

Eligibility Incurable Colorectal Cancer NCT02071069

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Colorectal cancer metastatic
Item
1. patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
boolean
C0001779 (UMLS CUI [1])
C0948380 (UMLS CUI [2])
ECOG performance status
Item
2. eastern cooperative oncology group performance status ≤2 and
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy of >3 months were enrolled.
boolean
C0023671 (UMLS CUI [1])
Measurable lesion Quantity
Item
4. all patients had to have at least one measurable lesion according to the response evaluation criteria in solid tumors (recist, version 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Absence Exposure to Cetuximab | Absence Exposure to Irinotecan
Item
5. none was previous exposure to cetuximab or irinotecan .
boolean
C0332197 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0995188 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0123931 (UMLS CUI [2,3])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver function | Serum total bilirubin measurement
Item
6. patients had to have adequate haematological (absolute neutrophil count >1.5 × 109/l; platelet count >100 × 109/l; haemoglobin >9 g/dl), hepatic [total bilirubin <1.5 ×
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of bone
Item
the upper limit of normal (uln); alanine aminotransferase and aspartate aminotransferase <2.5 × uln, or <5 × uln in the case of hepatic metastases or <10 ×
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0153690 (UMLS CUI [4])
Alkaline phosphatase measurement | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of bone | Renal function | Creatinine clearance measurement
Item
uln in the case of osseous metastases; alkaline phosphatase <2.5 × uln, or <5 × uln or <10 × uln in the case of hepatic or osseous metastases, respectively] and renal function (creatinine clearance ≥60 ml/min)
boolean
C0201850 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0153690 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
RAS Wild Type
Item
7. all ras were wildtype. -
boolean
C4331207 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or breast-feeding women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease
Item
2. clinically significant cardiac disease;
boolean
C0018799 (UMLS CUI [1])
Upper gastrointestinal tract | Integrity Physical Lacking
Item
3. lack of physical integrity of the upper gastrointestinal tract;
boolean
C1268997 (UMLS CUI [1])
C1947912 (UMLS CUI [2,1])
C0205485 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Cancer Other
Item
4. history of other malignancy;
boolean
C1707251 (UMLS CUI [1])
CNS metastases
Item
5. central nervous system metastases. -
boolean
C0686377 (UMLS CUI [1])
Terug naar het begin van de pagina 

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