ID

19740

Description

The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00243347

Link

https://clinicaltrials.gov/show/NCT00243347

Keywords

Versions (1)
  1. 1/25/17 1/25/17 -
Uploaded on

January 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma NCT00243347

English

Eligibility Carcinoma NCT00243347

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00243347
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed head and neck cancer (hnc) or unresectable stage iiib or iv non-small cell lung cancer (nsclc)
Description

Cancer of Head and Neck | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0278996
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C3258246
at least one lesion able to be used for tumor biopsy and to be measured by fdg-pet scan
Description

Lesion Quantity Neoplasm Biopsy | Measurable Disease Quantity FDG-Positron Emission Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027651
UMLS CUI [1,4]
C0005558
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C3641247
considered suitable for treatment of nsclc with no prior biological or immunological therapy for disease
Description

Therapeutic procedure Amenable Non-Small Cell Lung Carcinoma | Biological treatment Disease | Immunotherapy Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0007131
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0012634
or considered suitable for treatment for metastatic or recurrent hnc with no prior biological or immunological therapy for disease
Description

Therapeutic procedure Amenable Head and neck cancer metastatic | Therapeutic procedure Amenable Recurrent Head and Neck Carcinoma | Biological treatment Disease | Immunotherapy Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0744619
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1335703
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0012634
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0012634
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nsclc: have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of azd2171
Description

Chemotherapy Regimen Quantity Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure | AZD2171

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007131
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1541530
hnc: previous chemotherapy or radiotherapy if received 28 days of first dose of azd2171
Description

Chemotherapy Cancer of Head and Neck | Therapeutic radiology procedure | AZD2171

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278996
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1541530
untreatable, unstable brain or meningeal metastases.
Description

Metastatic malignant neoplasm to brain Unstable Untreated | Metastatic Malignant Neoplasm to the Leptomeninges Unstable Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0332155
abnormal liver and kidney blood chemistries
Description

Blood chemistry abnormal Liver | Blood chemistry abnormal Kidney

Data type

boolean

Alias
UMLS CUI [1,1]
C0438258
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0438258
UMLS CUI [2,2]
C0022646
history of poorly controlled hypertension with resting blood pressure of >150/100
Description

Poor hypertension control Blood pressure At rest

Data type

boolean

Alias
UMLS CUI [1,1]
C0421190
UMLS CUI [1,2]
C1271104
UMLS CUI [1,3]
C0443144
recent (< 14 days) major surgery or a surgical incision not fully healed
Description

major surgery | Surgical incision Healed Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0184898
UMLS CUI [2,2]
C0205249
UMLS CUI [2,3]
C0205257
diabetes patients with type i insulin dependent diabetes or poorly controlled type ii
Description

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
significant hemorrhage or hemoptysis
Description

Hemorrhage Significant | Hemoptysis Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0019079
UMLS CUI [2,2]
C0750502
presence of necrotic/hemorrhagic tumor or metastases
Description

Necrotic tumor | Hemorrhagic tumor | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1300818
UMLS CUI [2]
C1300819
UMLS CUI [3]
C0027627
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Similar models

Eligibility Carcinoma NCT00243347

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00243347
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cancer of Head and Neck | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging
Item
histologically or cytologically confirmed head and neck cancer (hnc) or unresectable stage iiib or iv non-small cell lung cancer (nsclc)
boolean
C0278996 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Lesion Quantity Neoplasm Biopsy | Measurable Disease Quantity FDG-Positron Emission Tomography
Item
at least one lesion able to be used for tumor biopsy and to be measured by fdg-pet scan
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3641247 (UMLS CUI [2,3])
Therapeutic procedure Amenable Non-Small Cell Lung Carcinoma | Biological treatment Disease | Immunotherapy Disease
Item
considered suitable for treatment of nsclc with no prior biological or immunological therapy for disease
boolean
C0087111 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
Therapeutic procedure Amenable Head and neck cancer metastatic | Therapeutic procedure Amenable Recurrent Head and Neck Carcinoma | Biological treatment Disease | Immunotherapy Disease
Item
or considered suitable for treatment for metastatic or recurrent hnc with no prior biological or immunological therapy for disease
boolean
C0087111 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0744619 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1335703 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Regimen Quantity Non-Small Cell Lung Carcinoma | Therapeutic radiology procedure | AZD2171
Item
nsclc: have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of azd2171
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C1541530 (UMLS CUI [3])
Chemotherapy Cancer of Head and Neck | Therapeutic radiology procedure | AZD2171
Item
hnc: previous chemotherapy or radiotherapy if received 28 days of first dose of azd2171
boolean
C0392920 (UMLS CUI [1,1])
C0278996 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C1541530 (UMLS CUI [3])
Metastatic malignant neoplasm to brain Unstable Untreated | Metastatic Malignant Neoplasm to the Leptomeninges Unstable Untreated
Item
untreatable, unstable brain or meningeal metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1704231 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Blood chemistry abnormal Liver | Blood chemistry abnormal Kidney
Item
abnormal liver and kidney blood chemistries
boolean
C0438258 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0438258 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
Poor hypertension control Blood pressure At rest
Item
history of poorly controlled hypertension with resting blood pressure of >150/100
boolean
C0421190 (UMLS CUI [1,1])
C1271104 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
major surgery | Surgical incision Healed Incomplete
Item
recent (< 14 days) major surgery or a surgical incision not fully healed
boolean
C0679637 (UMLS CUI [1])
C0184898 (UMLS CUI [2,1])
C0205249 (UMLS CUI [2,2])
C0205257 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
diabetes patients with type i insulin dependent diabetes or poorly controlled type ii
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Hemorrhage Significant | Hemoptysis Significant
Item
significant hemorrhage or hemoptysis
boolean
C0019080 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0019079 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Necrotic tumor | Hemorrhagic tumor | Neoplasm Metastasis
Item
presence of necrotic/hemorrhagic tumor or metastases
boolean
C1300818 (UMLS CUI [1])
C1300819 (UMLS CUI [2])
C0027627 (UMLS CUI [3])
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