ID

21453

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00283244

Nyckelord

Versioner (1)
  1. 2017-04-22 2017-04-22 -
Uppladdad den

22 april 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Lung Cancer NCT00283244

Engelsk

Eligibility Lung Cancer NCT00283244

1 Formulär  
Criteria
Beskrivning

Criteria

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

Non-Small Cell Lung Carcinoma

Datatyp

boolean

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

Disease TNM clinical staging

Datatyp

boolean

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

Measurable Disease

Datatyp

boolean

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

Metastatic malignant neoplasm to brain Asymptomatic Treated

Datatyp

boolean

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

Client Characteristics

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Absolute neutrophil count

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

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

Alkaline phosphatase measurement

Datatyp

boolean

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

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin normal
Beskrivning

Serum bilirubin normal

Datatyp

boolean

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

Gemcitabine hydrochloride Hypersensitivity Severe Absent

Datatyp

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
Beskrivning

Comorbidity Severe Absent

Datatyp

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
Beskrivning

Participation Able Assessment of quality of life

Datatyp

boolean

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

Therapeutic procedure

Datatyp

boolean

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

Neoplasm/cancer surgery Patient recovered | Major surgery Patient recovered

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Neoadjuvant Therapy | Adjuvant therapy

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Investigational New Drugs Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332197
Tillbaka till toppen

Similar models

Eligibility Lung Cancer NCT00283244

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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