ID

27400

Description

Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00735904

Link

https://clinicaltrials.gov/show/NCT00735904

Keywords

Versions (1)
  1. 11/13/17 11/13/17 -
Copyright Holder

See clinicaltrials.gov

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November 13, 2017

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung (NSCLC) NCT00735904

English

Eligibility Carcinoma, Non-Small-Cell Lung (NSCLC) NCT00735904

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically-confirmed diagnosis of squamous nsclc stage iiib with malignant effusion (fluid cytology demonstrating malignant cells required), stage iv, or recurrent disease after definitive local therapy
Description

Non-Small Cell Lung Carcinoma Squamous TNM clinical staging | Malignant Effusion | Local Therapy | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1182670
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3]
C1517925
UMLS CUI [4]
C0277556
candidate for primary treatment with cisplatin and gemcitabine
Description

First line treatment | Cisplatin | gemcitabine

Data type

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C0008838
UMLS CUI [3]
C0045093
presence of measurable disease by recist
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
adequate organ function as defined by the following criteria: ecog performance status of 0 or 1
Description

Organ function | ECOG performance status

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic treatment for stage iiib (with malignant effusion) or stage iv nsclc.
Description

Systemic therapy Non-Small Cell Lung Carcinoma TNM clinical staging | Malignant Effusion | Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C3258246
one or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by ct or mri.
Description

Lesion of lung Quantity | Cavitation | Lesion Blood Vessel Major CT | Lesion Blood Vessel Major MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0577916
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0578537
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0005847
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0040405
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0005847
UMLS CUI [4,3]
C0205164
UMLS CUI [4,4]
C0024485
history of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or grade 3 or 4 hemoptysis within 4 weeks of study treatment
Description

Hemoptysis Amount Duration | Hemoptysis Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0019079
UMLS CUI [2,2]
C0441800
nci ctcae grade 3 hemorrhage from any cause within 4 weeks of study treatment
Description

Hemorrhage CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
Description

Uncontrolled hypertension Pre-existing | Blood pressure finding Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1271104
UMLS CUI [2,2]
C1265611
untreated brain metastases.
Description

Metastatic malignant neoplasm to brain Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), nsaid or other medications known to inhibit platelet function.
Description

Anticoagulation Therapy Patient need for | Aspirin Regular U/day | NSAID Regular | Platelet Inhibitors Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0205272
UMLS CUI [4,1]
C0032188
UMLS CUI [4,2]
C0205272
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung (NSCLC) NCT00735904

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Squamous TNM clinical staging | Malignant Effusion | Local Therapy | Recurrent disease
Item
histologically- or cytologically-confirmed diagnosis of squamous nsclc stage iiib with malignant effusion (fluid cytology demonstrating malignant cells required), stage iv, or recurrent disease after definitive local therapy
boolean
C0007131 (UMLS CUI [1,1])
C1182670 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0080032 (UMLS CUI [2])
C1517925 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
First line treatment | Cisplatin | gemcitabine
Item
candidate for primary treatment with cisplatin and gemcitabine
boolean
C1708063 (UMLS CUI [1])
C0008838 (UMLS CUI [2])
C0045093 (UMLS CUI [3])
Measurable Disease
Item
presence of measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
Organ function | ECOG performance status
Item
adequate organ function as defined by the following criteria: ecog performance status of 0 or 1
boolean
C0678852 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Non-Small Cell Lung Carcinoma TNM clinical staging | Malignant Effusion | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
prior systemic treatment for stage iiib (with malignant effusion) or stage iv nsclc.
boolean
C1515119 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0080032 (UMLS CUI [2])
C0007131 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Lesion of lung Quantity | Cavitation | Lesion Blood Vessel Major CT | Lesion Blood Vessel Major MRI
Item
one or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by ct or mri.
boolean
C0577916 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0578537 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0005847 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0040405 (UMLS CUI [3,4])
C0221198 (UMLS CUI [4,1])
C0005847 (UMLS CUI [4,2])
C0205164 (UMLS CUI [4,3])
C0024485 (UMLS CUI [4,4])
Hemoptysis Amount Duration | Hemoptysis Grade
Item
history of hemoptysis > ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or grade 3 or 4 hemoptysis within 4 weeks of study treatment
boolean
C0019079 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0019079 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Hemorrhage CTCAE Grades
Item
nci ctcae grade 3 hemorrhage from any cause within 4 weeks of study treatment
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Uncontrolled hypertension Pre-existing | Blood pressure finding Quantity
Item
preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
boolean
C1868885 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1271104 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Untreated
Item
untreated brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Anticoagulation Therapy Patient need for | Aspirin Regular U/day | NSAID Regular | Platelet Inhibitors Regular
Item
need for therapeutic anticoagulation, regular use of aspirin (> 325 mg/day), nsaid or other medications known to inhibit platelet function.
boolean
C0003281 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0003211 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0032188 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
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