ID

36603

Beschrijving

High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02027090

Link

https://clinicaltrials.gov/show/NCT02027090

Trefwoorden

Versies (1)
  1. 26-05-19 26-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02027090

Engels

Eligibility Non-small Cell Lung Cancer NCT02027090

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology);
Beschrijving

Carcinoma of lung TNM clinical staging | Sputum Cytology Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1521752
UMLS CUI [2,2]
C0332196
pretreated with at least 1 platinum-based chemotherapy;
Beschrijving

Pretreatment Chemotherapy Platinum-Based

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1514162
no previous targeted treatment such as gefitinib, erlotinib;
Beschrijving

Targeted Therapy Absent | Gefitinib Absent | Erlotinib Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1122962
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1135135
UMLS CUI [3,2]
C0332197
with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) according to recist criteria;
Beschrijving

Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0552406
UMLS CUI [2,2]
C0860888
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0040405
who performance status(ps)<= 2;
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
adequate organ functions;
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
signed and dated informed consent before the start of specific protocol procedures.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic to icotinib;
Beschrijving

Hypersensitivity Icotinib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2604307
patients with metastatic brain tumors with symptoms;
Beschrijving

Symptoms Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0220650
experience of anti-egfr(the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab;
Beschrijving

Anti-EGFR Monoclonal Antibody | Small Molecule Compound Therapy | gefitinib | erlotinib | cetuximab

Datatype

boolean

Alias
UMLS CUI [1]
C4522190
UMLS CUI [2,1]
C1328819
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C1122962
UMLS CUI [4]
C1135135
UMLS CUI [5]
C0995188
severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Beschrijving

Systemic disease Severe Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0035204
UMLS CUI [6,2]
C0205433
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0205433
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C0205433
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02027090

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of lung TNM clinical staging | Sputum Cytology Excluded
Item
histologically or cytologically confirmed stage iiib/iv lung cancer(exclude patients confirmed by sputum cytology);
boolean
C0684249 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1521752 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Pretreatment Chemotherapy Platinum-Based
Item
pretreated with at least 1 platinum-based chemotherapy;
boolean
C3539076 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
Targeted Therapy Absent | Gefitinib Absent | Erlotinib Absent
Item
no previous targeted treatment such as gefitinib, erlotinib;
boolean
C2985566 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1122962 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1135135 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Measurable Disease | Longest Diameter Spiral CT | Longest Diameter CT
Item
with a measurable disease(longest diameters >=10mm with spiral computed tomography (ct)and >=20mm with conventional ct) according to recist criteria;
boolean
C1513041 (UMLS CUI [1])
C0552406 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0552406 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
WHO performance status scale
Item
who performance status(ps)<= 2;
boolean
C1298650 (UMLS CUI [1])
Organ function
Item
adequate organ functions;
boolean
C0678852 (UMLS CUI [1])
Informed Consent
Item
signed and dated informed consent before the start of specific protocol procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Icotinib
Item
allergic to icotinib;
boolean
C0020517 (UMLS CUI [1,1])
C2604307 (UMLS CUI [1,2])
Symptoms Metastatic malignant neoplasm to brain
Item
patients with metastatic brain tumors with symptoms;
boolean
C1457887 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
Anti-EGFR Monoclonal Antibody | Small Molecule Compound Therapy | gefitinib | erlotinib | cetuximab
Item
experience of anti-egfr(the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab;
boolean
C4522190 (UMLS CUI [1])
C1328819 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1122962 (UMLS CUI [3])
C1135135 (UMLS CUI [4])
C0995188 (UMLS CUI [5])
Systemic disease Severe Uncontrolled | Respiration Disorder Unstable | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Respiration Disorder Uncompensated | Heart Disease Uncompensated | Liver disease Uncompensated | Kidney Disease Uncompensated
Item
severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6,1])
C0205433 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0205433 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
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