ID

22193

Beschrijving

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/NCT02507375

Link

https://clinicaltrials.gov/show/NCT02507375

Trefwoorden

Versies (1)
  1. 22-05-17 22-05-17 -
Geüploaded op

22 mei 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 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.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

Engels

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Adult | Age

Datatype

boolean

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

Non-Small Cell Lung Carcinoma

Datatype

boolean

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

Disease Advanced Local | Neoplasm Metastasis

Datatype

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
Beschrijving

Disease Advanced Local | Neoplasm Metastasis | Chemotherapy Regimen Quantity failed

Datatype

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
Beschrijving

Life Expectancy

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

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
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Willing

Datatype

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
Beschrijving

Tumor Formalin-fixed paraffin-embedded tissue Availability of

Datatype

boolean

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

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Cardiovascular Disease

Datatype

boolean

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

CNS metastases | CNS metastases Evidence of

Datatype

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)
Beschrijving

Investigational New Drugs

Datatype

boolean

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

Doxorubicin Cumulative Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
Terug naar het begin van de pagina

Similar models

Eligibility Non-Squamous Non-Small Cell Lung Cancer NCT02507375

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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