ID

36607

Beskrivning

Icotinib and Arsenic Trioxide in Treating Non-small-cell Lung Cancer Patients With Resistance to EGFR-TKI; ODM derived from: https://clinicaltrials.gov/show/NCT02066870

Länk

https://clinicaltrials.gov/show/NCT02066870

Nyckelord

Versioner (1)
  1. 2019-05-26 2019-05-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02066870

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02066870

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed stage iiib/iv lung cancer with egfr mutation
Beskrivning

Carcinoma of lung TNM clinical staging | EGFR mutation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0684249
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C3266992
progressed after platinum-based chemotherapy
Beskrivning

Disease Progression | Status post Chemotherapy Platinum-Based

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C1514162
the last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
Beskrivning

Cancer treatment | gefitinib | erlotinib | icotinib | Tumor Response Duration | Stable Disease Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1122962
UMLS CUI [3]
C1135135
UMLS CUI [4]
C2604307
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C1704632
UMLS CUI [5,3]
C0449238
UMLS CUI [6,1]
C0677946
UMLS CUI [6,2]
C0449238
with a measurable disease with conventional ct) according to recist criteria
Beskrivning

Measurable Disease CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
who performance status(ps)<= 2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
n>=1.5×109/l, plt>=1.0×109/l,hb>=9g/dl; ast&alt should <2.5uln(without liver metastasis) or <5uln(with liver metastasis).tbil<=1.5uln.
Beskrivning

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6,1]
C0494165
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0494165
UMLS CUI [8]
C1278039
signed and dated informed consent before the start of specific protocol procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic to icotinib or arsenic trioxide.
Beskrivning

Hypersensitivity Icotinib | Hypersensitivity Arsenic trioxide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2604307
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0052416
patients with metastatic brain tumors with symptoms.
Beskrivning

Symptoms Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0220650
severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Beskrivning

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

Datatyp

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 NCT02066870

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of lung TNM clinical staging | EGFR mutation
Item
histologically or cytologically confirmed stage iiib/iv lung cancer with egfr mutation
boolean
C0684249 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3266992 (UMLS CUI [2])
Disease Progression | Status post Chemotherapy Platinum-Based
Item
progressed after platinum-based chemotherapy
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
Cancer treatment | gefitinib | erlotinib | icotinib | Tumor Response Duration | Stable Disease Duration
Item
the last anti-tumor therapy before entering this study must be gefitinib, erlotinib or icotinib, and the duration for tumor response must be no less than 4 months, or the duration for stable disease must be no less than 6 months
boolean
C0920425 (UMLS CUI [1])
C1122962 (UMLS CUI [2])
C1135135 (UMLS CUI [3])
C2604307 (UMLS CUI [4])
C0027651 (UMLS CUI [5,1])
C1704632 (UMLS CUI [5,2])
C0449238 (UMLS CUI [5,3])
C0677946 (UMLS CUI [6,1])
C0449238 (UMLS CUI [6,2])
Measurable Disease CT
Item
with a measurable disease with conventional ct) according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
WHO performance status scale
Item
who performance status(ps)<= 2
boolean
C1298650 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver | Serum total bilirubin measurement
Item
n>=1.5×109/l, plt>=1.0×109/l,hb>=9g/dl; ast&alt should <2.5uln(without liver metastasis) or <5uln(with liver metastasis).tbil<=1.5uln.
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0494165 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0494165 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
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 | Hypersensitivity Arsenic trioxide
Item
allergic to icotinib or arsenic trioxide.
boolean
C0020517 (UMLS CUI [1,1])
C2604307 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0052416 (UMLS CUI [2,2])
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])
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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