ID

17936

Description

Carboplatin and Docetaxel After Surgery in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00280735

Link

https://clinicaltrials.gov/show/NCT00280735

Keywords

Versions (1)
  1. 10/10/16 10/10/16 -
Uploaded on

October 10, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Lung Cancer NCT00280735

English

Eligibility Lung Cancer NCT00280735

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
stage i-iiia disease
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
must have undergone a complete resection
Description

Complete excision Received

Data type

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C1514756
must begin adjuvant chemotherapy within 8 weeks of surgical resection
Description

Adjuvant Chemotherapy Started | Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1272689
UMLS CUI [2]
C0728940
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count ≥ 1,500/mm^3
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin ≥ 8.0 g/dl
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
platelet count ≥ 100,000/mm^3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine normal or creatinine clearance ≥ 40 ml/min
Description

Serum creatinine normal | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0438244
UMLS CUI [2]
C0373595
bilirubin normal
Description

Bilirubin normal

Data type

boolean

Alias
UMLS CUI [1]
C0858307
alkaline phosphatase (ap), ast, and alt must meet 1 of the following criteria:
Description

Alkaline Phosphatase | Aspartate Transaminase | Alanine Transaminase

Data type

boolean

Alias
UMLS CUI [1]
C0002059
UMLS CUI [2]
C0004002
UMLS CUI [3]
C0001899
ap normal and ast and alt ≤ 5 times upper limit of normal (uln)
Description

Alkaline phosphatase normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0858306
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln
Description

Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
ap ≤ 5 times uln and ast and alt normal
Description

Alkaline phosphatase measurement | Aspartate aminotransferase normal | Alanine aminotransferase normal

Data type

boolean

Alias
UMLS CUI [1]
C0201850
UMLS CUI [2]
C0855624
UMLS CUI [3]
C0855620
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception during and for at least 3 months after study therapy
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
no peripheral neuropathy ≥ grade 2
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
no history of severe hypersensitivity to docetaxel or polysorbate 80
Description

severe allergy docetaxel | severe allergy Polysorbate 80

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient
Description

Malignant Neoplasms | Indication Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0085533
prior concurrent therapy:
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
2-8 weeks since prior surgery and recovered
Description

Operative Surgical Procedure | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
Back to the top of the page

Similar models

Eligibility Lung Cancer NCT00280735

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
stage i-iiia disease
boolean
C3258246 (UMLS CUI [1])
Complete excision Received
Item
must have undergone a complete resection
boolean
C0015250 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Adjuvant Chemotherapy Started | Excision
Item
must begin adjuvant chemotherapy within 8 weeks of surgical resection
boolean
C0085533 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥ 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin ≥ 8.0 g/dl
boolean
C0019046 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum creatinine normal | Creatinine clearance measurement
Item
serum creatinine normal or creatinine clearance ≥ 40 ml/min
boolean
C0438244 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Bilirubin normal
Item
bilirubin normal
boolean
C0858307 (UMLS CUI [1])
Alkaline Phosphatase | Aspartate Transaminase | Alanine Transaminase
Item
alkaline phosphatase (ap), ast, and alt must meet 1 of the following criteria:
boolean
C0002059 (UMLS CUI [1])
C0004002 (UMLS CUI [2])
C0001899 (UMLS CUI [3])
Alkaline phosphatase normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ap normal and ast and alt ≤ 5 times upper limit of normal (uln)
boolean
C0858306 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ap ≤ 2.5 times uln and ast and alt ≤ 1.5 times uln
boolean
C0201850 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Alkaline phosphatase measurement | Aspartate aminotransferase normal | Alanine aminotransferase normal
Item
ap ≤ 5 times uln and ast and alt normal
boolean
C0201850 (UMLS CUI [1])
C0855624 (UMLS CUI [2])
C0855620 (UMLS CUI [3])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for at least 3 months after study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Breast Feeding
Item
no breastfeeding
boolean
C0006147 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
no peripheral neuropathy ≥ grade 2
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
severe allergy docetaxel | severe allergy Polysorbate 80
Item
no history of severe hypersensitivity to docetaxel or polysorbate 80
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
Malignant Neoplasms | Indication Chemotherapy, Adjuvant
Item
prior history of malignancy allowed provided the attending medical oncologists believes that adjuvant chemotherapy is indicated and will potentially benefit the patient
boolean
C0006826 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
Operative Surgical Procedure | Patient Recovered
Item
2-8 weeks since prior surgery and recovered
boolean
C0543467 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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