ID

18452

Beschrijving

Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00073723

Link

https://clinicaltrials.gov/show/NCT00073723

Trefwoorden

Versies (1)
  1. 06-11-16 06-11-16 -
Geüploaded op

6 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00073723

Engels

Eligibility Non-Small Cell Lung Cancer NCT00073723

1 Formulieren  
Criteria
Beschrijving

Criteria

histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
Beschrijving

Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C2825055
UMLS CUI [3,3]
C0205276
UMLS CUI [3,4]
C0205187
UMLS CUI [3,5]
C0332120
if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
Beschrijving

Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430061
UMLS CUI [4]
C3831118
UMLS CUI [5]
C0700589
eighteen years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
no other current active malignancy
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
measurable disease (defined by recist criteria) documented radiographically
Beschrijving

Measurable Disease | Radiography

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0034571
patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
Beschrijving

Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0205146
UMLS CUI [2,5]
C0205164
UMLS CUI [3,1]
C0242275
UMLS CUI [3,2]
C2985566
if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
Beschrijving

Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0860928
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0201850
UMLS CUI [6,1]
C0151849
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C0153690
UMLS CUI [7,1]
C0494165
UMLS CUI [7,2]
C3887511
UMLS CUI [7,3]
C0205483
expected survival of greater than 12 weeks
Beschrijving

Continuance of life Expected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038952
UMLS CUI [1,2]
C1517001
ecog performance status 0-1 (karnofsky > 70)
Beschrijving

ECOG performance status | Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
Beschrijving

Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0023226
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00073723

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of
Item
histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C2825055 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
C0205187 (UMLS CUI [3,4])
C0332120 (UMLS CUI [3,5])
Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods
Item
if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
Age
Item
eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasms
Item
no other current active malignancy
boolean
C0006826 (UMLS CUI [1])
Measurable Disease | Radiography
Item
measurable disease (defined by recist criteria) documented radiographically
boolean
C1513041 (UMLS CUI [1])
C0034571 (UMLS CUI [2])
Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy
Item
patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0205146 (UMLS CUI [2,4])
C0205164 (UMLS CUI [2,5])
C0242275 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic
Item
if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0860928 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0151849 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0153690 (UMLS CUI [6,3])
C0494165 (UMLS CUI [7,1])
C3887511 (UMLS CUI [7,2])
C0205483 (UMLS CUI [7,3])
Continuance of life Expected
Item
expected survival of greater than 12 weeks
boolean
C0038952 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status 0-1 (karnofsky > 70)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian
Item
patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
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