ID

38579

Descripción

Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung; ODM derived from: https://clinicaltrials.gov/show/NCT01236716

Link

https://clinicaltrials.gov/show/NCT01236716

Palabras clave

Versiones (1)
  1. 24/10/19 24/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01236716

Inglés

Eligibility Carcinoma, Non-Small-Cell Lung NCT01236716

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated, histological documented stage iiib (not amenable for radical regional therapy) or stage iv squamous cell carcinoma of lung. at least one measurable lesion as defined by recist criteria.
Descripción

Therapy naive | Squamous cell carcinoma of lung TNM clinical staging | Squamous cell carcinoma of lung Inappropriate Radical therapy | Measurable lesion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0149782
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0149782
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0260176
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C1265611
at least 18 years of age.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog ps 0~1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
Descripción

History of cancer Absent | Exception Carcinoma in situ of uterine cervix Cured | Exception Basal cell carcinoma Cured | Exception Superficial carcinoma of urinary bladder Cured | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Recurrent disease | Status post Neoadjuvant Chemotherapy Discontinued | Status post Adjuvant Chemotherapy Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0455471
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [4,3]
C1880198
UMLS CUI [5,1]
C0600558
UMLS CUI [5,2]
C3665472
UMLS CUI [6]
C0085533
UMLS CUI [7]
C0277556
UMLS CUI [8,1]
C0231290
UMLS CUI [8,2]
C0600558
UMLS CUI [8,3]
C3665472
UMLS CUI [8,4]
C1444662
UMLS CUI [9,1]
C0231290
UMLS CUI [9,2]
C0085533
UMLS CUI [9,3]
C1444662
neutrophil ≥ 1.5 x 109 /l, hemoglobin > 90 g/l, platelet count > 100x109/l.
Descripción

Neutrophil count | Hemoglobin measurement | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
total bilirubin ≤ 1.5 x upper limit of normal. alt and ast < 2.5 x upper limit of normal without liver metastasis, alt and ast < 5 x upper limit of normal with liver metastasis. serum creatinine < 1.5 x upper limit of normal.
Descripción

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0150312
UMLS CUI [6]
C0201976
urine pregnancy test is negative for woman.
Descripción

Gender | Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0430057
estimated life expectancy is at least 3 months.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
patient comply with the clinical trial protocal.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
informed consent must be signed.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are currently undergoing other anti-tumor therapy.
Descripción

Cancer treatment Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
patients who was enrolled in any other clinical trial within 4 weeks of study entry.
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
Descripción

Physical Examination Finding Suspicious | Laboratory test finding Suspicious | Disease Investigational New Drugs Contraindicated | Condition Investigational New Drugs Contraindicated | Disease Treatment At risk | Condition Treatment At risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0750493
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C0750493
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1444657
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1444657
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C1444641
central nervous system (cns) tumor or metastatic tumor.
Descripción

Central Nervous System Neoplasms | CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2]
C0686377
serious mental disorder.
Descripción

Serious mental illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3841614
serious dysgnosia.
Descripción

Other Coding | Agnosia Mild Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0001816
UMLS CUI [2,2]
C2945599
UMLS CUI [2,3]
C0205404
other serious comorbidity.
Descripción

Comorbidity Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
alcohol or drug dependence.
Descripción

Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038580
previously allergic to drugs used in the study.
Descripción

Hypersensitivity Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01236716

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive | Squamous cell carcinoma of lung TNM clinical staging | Squamous cell carcinoma of lung Inappropriate Radical therapy | Measurable lesion Quantity
Item
previously untreated, histological documented stage iiib (not amenable for radical regional therapy) or stage iv squamous cell carcinoma of lung. at least one measurable lesion as defined by recist criteria.
boolean
C0919936 (UMLS CUI [1])
C0149782 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0149782 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0260176 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog ps 0~1
boolean
C1520224 (UMLS CUI [1])
History of cancer Absent | Exception Carcinoma in situ of uterine cervix Cured | Exception Basal cell carcinoma Cured | Exception Superficial carcinoma of urinary bladder Cured | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Recurrent disease | Status post Neoadjuvant Chemotherapy Discontinued | Status post Adjuvant Chemotherapy Discontinued
Item
patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
boolean
C0455471 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C0600558 (UMLS CUI [5,1])
C3665472 (UMLS CUI [5,2])
C0085533 (UMLS CUI [6])
C0277556 (UMLS CUI [7])
C0231290 (UMLS CUI [8,1])
C0600558 (UMLS CUI [8,2])
C3665472 (UMLS CUI [8,3])
C1444662 (UMLS CUI [8,4])
C0231290 (UMLS CUI [9,1])
C0085533 (UMLS CUI [9,2])
C1444662 (UMLS CUI [9,3])
Neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
neutrophil ≥ 1.5 x 109 /l, hemoglobin > 90 g/l, platelet count > 100x109/l.
boolean
C0200633 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Creatinine measurement, serum
Item
total bilirubin ≤ 1.5 x upper limit of normal. alt and ast < 2.5 x upper limit of normal without liver metastasis, alt and ast < 5 x upper limit of normal with liver metastasis. serum creatinine < 1.5 x upper limit of normal.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0494165 (UMLS CUI [5,1])
C0150312 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
Gender | Urine pregnancy test negative
Item
urine pregnancy test is negative for woman.
boolean
C0079399 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
Life Expectancy
Item
estimated life expectancy is at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Protocol Compliance
Item
patient comply with the clinical trial protocal.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
informed consent must be signed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Other
Item
patients who are currently undergoing other anti-tumor therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients who was enrolled in any other clinical trial within 4 weeks of study entry.
boolean
C2348568 (UMLS CUI [1])
Physical Examination Finding Suspicious | Laboratory test finding Suspicious | Disease Investigational New Drugs Contraindicated | Condition Investigational New Drugs Contraindicated | Disease Treatment At risk | Condition Treatment At risk
Item
any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
boolean
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
Central Nervous System Neoplasms | CNS metastases
Item
central nervous system (cns) tumor or metastatic tumor.
boolean
C0085136 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
Serious mental illness
Item
serious mental disorder.
boolean
C3841614 (UMLS CUI [1])
Other Coding | Agnosia Mild Serious
Item
serious dysgnosia.
boolean
C3846158 (UMLS CUI [1])
C0001816 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Comorbidity Serious
Item
other serious comorbidity.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Substance Dependence
Item
alcohol or drug dependence.
boolean
C0038580 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
previously allergic to drugs used in the study.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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