ID

40383

Description

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

Keywords

Versions (1)
  1. 4/16/20 4/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 16, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Incurable Colorectal Cancer NCT02071069

English

Eligibility Incurable Colorectal Cancer NCT02071069

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age | Colorectal cancer metastatic

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

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)
Description

Measurable lesion Quantity

Data type

boolean

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

Absence Exposure to Cetuximab | Absence Exposure to Irinotecan

Data type

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 ×
Description

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

Data type

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 ×
Description

| C0153690 Secondary malignant neoplasm of bone

Data type

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)
Description

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

Data type

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. -
Description

RAS Wild Type

Data type

boolean

Alias
UMLS CUI [1]
C4331207
Exclusion Criteria
Description

Exclusion Criteria

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

Pregnancy | Breast Feeding

Data type

boolean

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

Heart Disease

Data type

boolean

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

Upper gastrointestinal tract | Integrity Physical Lacking

Data type

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;
Description

Cancer Other

Data type

boolean

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

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
Back to the top of the page

Similar models

Eligibility Incurable Colorectal Cancer NCT02071069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial