ID

18407

Beschrijving

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00087711

Link

https://clinicaltrials.gov/show/NCT00087711

Trefwoorden

  1. 03-11-16 03-11-16 -
Geüploaded op

3 november 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Carcinoma NCT00087711

Eligibility Non Small Cell Lung Carcinoma NCT00087711

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nsclc stage iiib not amenable to curative treatment or stage iv.
Beschrijving

Non-Small Cell Lung Carcinoma | TNM clinical staging | Non-Small Cell Lung Carcinoma Amenable curative treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C1273390
no prior chemotherapy for lung cancer.
Beschrijving

Prior Chemotherapy Malignant neoplasm of lung

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0242379
patients must have at least one uni-dimensionally measurable lesion.
Beschrijving

Measurable Lesion Linear Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. radiation must be completed at least 4 weeks prior to study enrollment.
Beschrijving

prior radiation therapy Bone Marrow Percentage | Therapeutic radiology procedure Whole-Pelvis | Therapeutic radiology procedure Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C3827467
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any drug within the last 30 days that has not received regulatory approval.
Beschrijving

Drugs, Non-Prescription

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
serious cardiac condition.
Beschrijving

Heart condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C3842523
UMLS CUI [1,2]
C0205404
serious medical disorder in addition to nsclc that would make it difficult for the patient to complete the study.
Beschrijving

Disease Serious In addition to Non-Small Cell Lung Carcinoma | Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C0007131
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
inability or unwillingness to take folic acid or vitamin b12 supplementation.
Beschrijving

Folic Acid Intake Unwilling | Vitamin B12 supplement 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
presence of fluid retention that cannot be controlled by drainage.
Beschrijving

Body fluid retention | Drainage Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0268000
UMLS CUI [2,1]
C0013103
UMLS CUI [2,2]
C1272705

Similar models

Eligibility Non Small Cell Lung Carcinoma NCT00087711

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | TNM clinical staging | Non-Small Cell Lung Carcinoma Amenable curative treatment
Item
diagnosis of nsclc stage iiib not amenable to curative treatment or stage iv.
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C0007131 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C1273390 (UMLS CUI [3,3])
Prior Chemotherapy Malignant neoplasm of lung
Item
no prior chemotherapy for lung cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
Measurable Lesion Linear Quantity
Item
patients must have at least one uni-dimensionally measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
prior radiation therapy Bone Marrow Percentage | Therapeutic radiology procedure Whole-Pelvis | Therapeutic radiology procedure Completed
Item
prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. radiation must be completed at least 4 weeks prior to study enrollment.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C3827467 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription
Item
treatment with any drug within the last 30 days that has not received regulatory approval.
boolean
C0013231 (UMLS CUI [1])
Heart condition Serious
Item
serious cardiac condition.
boolean
C3842523 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Disease Serious In addition to Non-Small Cell Lung Carcinoma | Compliance behavior Limited
Item
serious medical disorder in addition to nsclc that would make it difficult for the patient to complete the study.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0007131 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Folic Acid Intake Unwilling | Vitamin B12 supplement Intake Unwilling
Item
inability or unwillingness to take folic acid or vitamin b12 supplementation.
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])
Body fluid retention | Drainage Unsuccessful
Item
presence of fluid retention that cannot be controlled by drainage.
boolean
C0268000 (UMLS CUI [1])
C0013103 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])

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