ID

18401

Description

Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00582634

Link

https://clinicaltrials.gov/show/NCT00582634

Keywords

  1. 11/3/16 11/3/16 -
Uploaded on

November 3, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Non Small Cell Lung Cancer NCT00582634

Eligibility Non Small Cell Lung Cancer NCT00582634

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage ib to iiia non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
Description

Non-Small Cell Lung Carcinoma Complete excision | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0015250
UMLS CUI [2]
C3258246
performance status ecog 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
peripheral neuropathy: < grade 1
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
adequate blood cell counts
Description

Blood Cell Count

Data type

boolean

Alias
UMLS CUI [1]
C0005771
adequate liver and hepatic function
Description

Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
women of childbearing potential must have a negative pregnancy test.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a history of severe hypersensitivity reaction to docetaxel® or other drugs formulated with polysorbate 80.
Description

severe allergy docetaxel | severe allergy Pharmaceutical Preparations Polysorbate 80 Based

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0032601
UMLS CUI [2,4]
C1705938
women who are breast-feeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
Description

Neoplasms, Second Primary | Malignant Neoplasm Previous | Basal cell carcinoma Curative treatment | Squamous cell carcinoma of skin Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1273390
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1273390
uncontrolled cardiac disease or uncontrolled hypertension
Description

Heart Disease Uncontrolled | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885

Similar models

Eligibility Non Small Cell Lung Cancer NCT00582634

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Complete excision | TNM clinical staging
Item
stage ib to iiia non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
boolean
C0007131 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
ECOG performance status
Item
performance status ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy: < grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Blood Cell Count
Item
adequate blood cell counts
boolean
C0005771 (UMLS CUI [1])
Liver function | Renal function
Item
adequate liver and hepatic function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Childbearing Potential Pregnancy test negative
Item
women of childbearing potential must have a negative pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
severe allergy docetaxel | severe allergy Pharmaceutical Preparations Polysorbate 80 Based
Item
patients with a history of severe hypersensitivity reaction to docetaxel® or other drugs formulated with polysorbate 80.
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0032601 (UMLS CUI [2,3])
C1705938 (UMLS CUI [2,4])
Breast Feeding
Item
women who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])
Neoplasms, Second Primary | Malignant Neoplasm Previous | Basal cell carcinoma Curative treatment | Squamous cell carcinoma of skin Curative treatment
Item
coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
boolean
C0085183 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
Heart Disease Uncontrolled | Uncontrolled hypertension
Item
uncontrolled cardiac disease or uncontrolled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])

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