ID

41185

Beschrijving

Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00955695

Link

https://clinicaltrials.gov/show/NCT00955695

Trefwoorden

  1. 07-07-20 07-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 juli 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Lung Cancer NCT00955695

Eligibility Lung Cancer NCT00955695

Criteria
Beschrijving

Criteria

histologically confirmed non-small cell lung cancer
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

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

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
Beschrijving

gefitinib | erlotinib hydrochloride

Datatype

boolean

Alias
UMLS CUI [1]
C1122962
UMLS CUI [2]
C1533491
at least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
Beschrijving

Complete remission | Partial response | gefitinib | erlotinib hydrochloride

Datatype

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3]
C1122962
UMLS CUI [4]
C1533491
stable disease allowed provided 1 of the following criteria is met:
Beschrijving

Stable Disease | Criteria Quantity Fulfill

Datatype

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1550543
egfr mutation (exon 19 or 21)
Beschrijving

EGFR Exon 19 Mutation | EGFR Exon 21 Mutation

Datatype

boolean

Alias
UMLS CUI [1]
C4289656
UMLS CUI [2]
C4289654
having ≥ 2 of the following 3 factors:
Beschrijving

Factor Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1265611
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
never smoked
Beschrijving

Never smoked tobacco

Datatype

boolean

Alias
UMLS CUI [1]
C0425293
histologically confirmed adenocarcinoma of the lung
Beschrijving

Adenocarcinoma of lung

Datatype

boolean

Alias
UMLS CUI [1]
C0152013
no evidence of brain metastases by ct scan or mri within the past 4 weeks
Beschrijving

Metastatic malignant neoplasm to brain Absent CT scan | Metastatic malignant neoplasm to brain Absent MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0024485
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

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

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
anc ≥ 1,500/mm^3
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 150,000/mm^3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
bilirubin < 1.5 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine < 1.5 times upper limit of normal
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
prior concurrent therapy:
Beschrijving

Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Beschrijving

ID.19

Datatype

boolean

received 1 or 2 prior systemic chemotherapy regimens
Beschrijving

Systemic Chemotherapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611

Similar models

Eligibility Lung Cancer NCT00955695

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
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])
gefitinib | erlotinib hydrochloride
Item
must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
boolean
C1122962 (UMLS CUI [1])
C1533491 (UMLS CUI [2])
Complete remission | Partial response | gefitinib | erlotinib hydrochloride
Item
at least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C1122962 (UMLS CUI [3])
C1533491 (UMLS CUI [4])
Stable Disease | Criteria Quantity Fulfill
Item
stable disease allowed provided 1 of the following criteria is met:
boolean
C0677946 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
EGFR Exon 19 Mutation | EGFR Exon 21 Mutation
Item
egfr mutation (exon 19 or 21)
boolean
C4289656 (UMLS CUI [1])
C4289654 (UMLS CUI [2])
Factor Quantity
Item
having ≥ 2 of the following 3 factors:
boolean
C1521761 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Never smoked tobacco
Item
never smoked
boolean
C0425293 (UMLS CUI [1])
Adenocarcinoma of lung
Item
histologically confirmed adenocarcinoma of the lung
boolean
C0152013 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Absent CT scan | Metastatic malignant neoplasm to brain Absent MRI
Item
no evidence of brain metastases by ct scan or mri within the past 4 weeks
boolean
C0220650 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
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/mm^3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 150,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin < 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 times upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.19
Item
see disease characteristics
boolean
Systemic Chemotherapy Quantity
Item
received 1 or 2 prior systemic chemotherapy regimens
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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