ID

40383

Descripción

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

Palabras clave

Versiones (1)
  1. 16/4/20 16/4/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de abril de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Incurable Colorectal Cancer NCT02071069

Inglés

Eligibility Incurable Colorectal Cancer NCT02071069

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age | Colorectal cancer metastatic

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

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)
Descripción

Measurable lesion Quantity

Tipo de datos

boolean

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

Absence Exposure to Cetuximab | Absence Exposure to Irinotecan

Tipo de datos

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 ×
Descripción

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

Tipo de datos

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 ×
Descripción

| C0153690 Secondary malignant neoplasm of bone

Tipo de datos

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)
Descripción

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

Tipo de datos

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. -
Descripción

RAS Wild Type

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4331207
Exclusion Criteria
Descripción

Exclusion Criteria

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Heart Disease

Tipo de datos

boolean

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

Upper gastrointestinal tract | Integrity Physical Lacking

Tipo de datos

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;
Descripción

Cancer Other

Tipo de datos

boolean

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

CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
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Similar models

Eligibility Incurable Colorectal Cancer NCT02071069

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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