ID

22195

Beschreibung

A Study of Pertuzumab in Combination With Erlotinib (Tarceva) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02514096

Link

https://clinicaltrials.gov/show/NCT02514096

Stichworte

Versionen (1)
  1. 22.05.17 22.05.17 -
Hochgeladen am

22. Mai 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02514096

Englisch

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02514096

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients greater than or equal to 18 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histological confirmation of non-small cell lung cancer (nsclc)
Beschreibung

Non-Small Cell Lung Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007131
locally advanced or metastatic disease
Beschreibung

Disease Advanced Local | Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0027627
failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
Beschreibung

Disease Advanced Local | Neoplasm Metastasis | Chemotherapy Regimen Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
life expectancy of more than or equal to 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
baseline lvef of greater than or equal to 50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
a negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0600109
availability of histological ffpe tumor tissue
Beschreibung

Tumor Formalin-fixed paraffin-embedded tissue Availability of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2711483
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
prior treatment with any agent which targets growth factors or their receptors
Beschreibung

Pharmaceutical Preparations Targeted Therapy Growth Factor | Pharmaceutical Preparations Targeted Therapy Growth Factor Receptors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0018284
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2985566
UMLS CUI [2,3]
C0206454
patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
Beschreibung

Chemotherapy Effects Reversible | Therapeutic radiology procedure Effects Reversible | Recovery Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0205343
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0205343
UMLS CUI [3,1]
C0237820
UMLS CUI [3,2]
C0332197
history of clinically significant cardiovascular disease
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
history or evidence of central nervous system metastases
Beschreibung

CNS metastases | CNS metastases Evidence of

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332120
treatment with any investigational drug within 28 days of the start of the study (day-8)
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
Beschreibung

Doxorubicin Cumulative Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02514096

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients greater than or equal to 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Small Cell Lung Carcinoma
Item
histological confirmation of non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Disease Advanced Local | Neoplasm Metastasis
Item
locally advanced or metastatic disease
boolean
C0012634 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2])
Disease Advanced Local | Neoplasm Metastasis | Chemotherapy Regimen Quantity failed
Item
failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
boolean
C0012634 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Life Expectancy
Item
life expectancy of more than or equal to 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
baseline lvef of greater than or equal to 50%
boolean
C0428772 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Willing
Item
a negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Tumor Formalin-fixed paraffin-embedded tissue Availability of
Item
availability of histological ffpe tumor tissue
boolean
C0027651 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Pharmaceutical Preparations Targeted Therapy Growth Factor | Pharmaceutical Preparations Targeted Therapy Growth Factor Receptors
Item
prior treatment with any agent which targets growth factors or their receptors
boolean
C0013227 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0206454 (UMLS CUI [2,3])
Chemotherapy Effects Reversible | Therapeutic radiology procedure Effects Reversible | Recovery Absent
Item
patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
C0237820 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiovascular Disease
Item
history of clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
CNS metastases | CNS metastases Evidence of
Item
history or evidence of central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Investigational New Drugs
Item
treatment with any investigational drug within 28 days of the start of the study (day-8)
boolean
C0013230 (UMLS CUI [1])
Doxorubicin Cumulative Dose
Item
prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video