ID

21453

Descripción

Gemcitabine and/or Erlotinib as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00283244

Link

https://clinicaltrials.gov/show/NCT00283244

Palabras clave

Versiones (1)
  1. 22/4/17 22/4/17 -
Subido en

22 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00283244

Inglés

Eligibility Lung Cancer NCT00283244

1 formularios  
Criteria
Descripción

Criteria

histologically or cytologically confirmed non-small cell lung cancer (nsclc)
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib or iv disease
Descripción

Disease TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
measurable disease by recist criteria
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
treated brain metastases allowed provided patient is asymptomatic
Descripción

Metastatic malignant neoplasm to brain Asymptomatic Treated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1522326
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1,500/mm³
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm³
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 8.0 g/dl
Descripción

Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
ast and alt ≤ 2.5 times upper limit of normal (uln)
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase ≤ 4 times uln
Descripción

Alkaline phosphatase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201850
creatinine ≤ 1.5 times uln
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin normal
Descripción

Serum bilirubin normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428443
no history of severe hypersensitivity to gemcitabine hydrochloride
Descripción

Gemcitabine hydrochloride Hypersensitivity Severe Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0771488
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C0332197
no severe comorbid illness
Descripción

Comorbidity Severe Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
able to participate in quality of life assessments
Descripción

Participation Able Assessment of quality of life

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0281588
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
recovered from prior oncologic or other major surgery
Descripción

Neoplasm/cancer surgery Patient recovered | Major surgery Patient recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0597029
UMLS CUI [1,2]
C1115804
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1115804
one prior treatment for nsclc allowed provided it was in the neoadjuvant or adjuvant setting
Descripción

Neoadjuvant Therapy Quantity Non-Small Cell Lung Carcinoma | Adjuvant therapy Quantity Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007131
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0007131
at least 1 year since prior treatment in the neoadjuvant or adjuvant setting
Descripción

Neoadjuvant Therapy | Adjuvant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0677850
no other concurrent antineoplastic or antitumor agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
Descripción

Antineoplastic Agents Absent | Cancer treatment Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Cancer hormonal therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0021083
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0877050
UMLS CUI [6,2]
C0332197
no other concurrent investigational agents
Descripción

Investigational New Drugs Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332197
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Similar models

Eligibility Lung Cancer NCT00283244

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically or cytologically confirmed non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iiib or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease by recist criteria
boolean
C1513041 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Asymptomatic Treated
Item
treated brain metastases allowed provided patient is asymptomatic
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1,500/mm³
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 2.5 times upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
alkaline phosphatase ≤ 4 times uln
boolean
C0201850 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 times uln
boolean
C0201976 (UMLS CUI [1])
Serum bilirubin normal
Item
bilirubin normal
boolean
C0428443 (UMLS CUI [1])
Gemcitabine hydrochloride Hypersensitivity Severe Absent
Item
no history of severe hypersensitivity to gemcitabine hydrochloride
boolean
C0771488 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Comorbidity Severe Absent
Item
no severe comorbid illness
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Participation Able Assessment of quality of life
Item
able to participate in quality of life assessments
boolean
C0679823 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0281588 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Neoplasm/cancer surgery Patient recovered | Major surgery Patient recovered
Item
recovered from prior oncologic or other major surgery
boolean
C0597029 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Neoadjuvant Therapy Quantity Non-Small Cell Lung Carcinoma | Adjuvant therapy Quantity Non-Small Cell Lung Carcinoma
Item
one prior treatment for nsclc allowed provided it was in the neoadjuvant or adjuvant setting
boolean
C0600558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
Neoadjuvant Therapy | Adjuvant therapy
Item
at least 1 year since prior treatment in the neoadjuvant or adjuvant setting
boolean
C0600558 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
Antineoplastic Agents Absent | Cancer treatment Absent | Chemotherapy Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Cancer hormonal therapy Absent
Item
no other concurrent antineoplastic or antitumor agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
boolean
C0003392 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0021083 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0877050 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Investigational New Drugs Absent
Item
no other concurrent investigational agents
boolean
C0013230 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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