ID

40383

Beschreibung

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

Stichworte

Versionen (1)
  1. 16.04.20 16.04.20 -
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See clinicaltrials.gov

Hochgeladen am

16. April 2020

DOI

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Eligibility Incurable Colorectal Cancer NCT02071069

Englisch

Eligibility Incurable Colorectal Cancer NCT02071069

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age | Colorectal cancer metastatic

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Life Expectancy

Datentyp

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)
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

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

Absence Exposure to Cetuximab | Absence Exposure to Irinotecan

Datentyp

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 ×
Beschreibung

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

Datentyp

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 ×
Beschreibung

| C0153690 Secondary malignant neoplasm of bone

Datentyp

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)
Beschreibung

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

Datentyp

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. -
Beschreibung

RAS Wild Type

Datentyp

boolean

Alias
UMLS CUI [1]
C4331207
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Heart Disease

Datentyp

boolean

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

Upper gastrointestinal tract | Integrity Physical Lacking

Datentyp

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;
Beschreibung

Cancer Other

Datentyp

boolean

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

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Incurable Colorectal Cancer NCT02071069

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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