ID

16519

Beschrijving

A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00190840

Link

https://clinicaltrials.gov/show/NCT00190840

Trefwoorden

Versies (1)
  1. 22-07-16 22-07-16 -
Geüploaded op

22 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

Engels

Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nsclc
Beschrijving

Non-Small Cell Lung Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
locally advanced or metastatic disease (stage iiib or iv).
Beschrijving

Locally Advanced Malignant Neoplasm | Metastatic Neoplasm | TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C0677984
UMLS CUI [2]
C2939420
UMLS CUI [3]
C3258246
patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
Beschrijving

Chemotherapy Palliative procedure Locally Advanced Malignant Neoplasm | Chemotherapy Palliative procedure Metastatic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1285158
UMLS CUI [1,3]
C0677984
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1285158
UMLS CUI [2,3]
C2939420
disease status must be that of measurable disease as defined by recist criteria
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale; and adequate organ function.
Beschrijving

ECOG performance status | organ function

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0678852
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected brain metastasis, or second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Beschrijving

Metastatic malignant neoplasm to brain | Second Primary Cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0751623
concurrent administration of any other tumor therapy.
Beschrijving

cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
history of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
Beschrijving

nervous system disorder Significant | Mental disorders Significant | Seizures | Dementia | Comorbidity Serious Affecting patient safety | Comorbidity Serious Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0497327
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C0392760
UMLS CUI [5,4]
C1113679
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1321605
UMLS CUI [6,4]
C0439801
inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of pemetrexed.
Beschrijving

Aspirin Interrupt Unable | Anti-Inflammatory Agents, Non-Steroidal Interrupt Unable | pemetrexed Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0443239
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0443239
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0210657
UMLS CUI [3,2]
C0178602
inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone
Beschrijving

Folic Acid Intake Unwilling | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016410
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3661610
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0011777
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0558080
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Similar models

Eligibility Carcinoma, Non-Small Cell Lung NCT00190840

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
Locally Advanced Malignant Neoplasm | Metastatic Neoplasm | TNM clinical staging
Item
locally advanced or metastatic disease (stage iiib or iv).
boolean
C0677984 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
Chemotherapy Palliative procedure Locally Advanced Malignant Neoplasm | Chemotherapy Palliative procedure Metastatic Neoplasm
Item
patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C1285158 (UMLS CUI [1,2])
C0677984 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1285158 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
Measurable Disease
Item
disease status must be that of measurable disease as defined by recist criteria
boolean
C1513041 (UMLS CUI [1])
ECOG performance status | organ function
Item
performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale; and adequate organ function.
boolean
C1520224 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Second Primary Cancer
Item
known or suspected brain metastasis, or second primary malignancy that is clinically detectable at the time of consideration for study enrollment
boolean
C0220650 (UMLS CUI [1])
C0751623 (UMLS CUI [2])
cancer treatment
Item
concurrent administration of any other tumor therapy.
boolean
C0920425 (UMLS CUI [1])
nervous system disorder Significant | Mental disorders Significant | Seizures | Dementia | Comorbidity Serious Affecting patient safety | Comorbidity Serious Compliance behavior Limited
Item
history of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0009488 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
C1113679 (UMLS CUI [5,4])
C0009488 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C0439801 (UMLS CUI [6,4])
Aspirin Interrupt Unable | Anti-Inflammatory Agents, Non-Steroidal Interrupt Unable | pemetrexed Dose
Item
inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of pemetrexed.
boolean
C0004057 (UMLS CUI [1,1])
C0443239 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0443239 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0210657 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
Folic Acid Intake Unwilling | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unwilling
Item
inability or unwillingness to take folic acid, vitamin b12 supplementation, or dexamethasone
boolean
C0016410 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3661610 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0011777 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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