ID

22081

Description

Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00431613

Link

https://clinicaltrials.gov/show/NCT00431613

Keywords

Versions (2)
  1. 5/18/17 5/18/17 -
  2. 5/18/17 5/18/17 -
Uploaded on

May 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00431613

English

Eligibility Non Small Cell Lung Cancer NCT00431613

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed, unresectable locally advanced (stage iiia/iiib) nsclc
Description

Non-Small Cell Lung Carcinoma Advanced Local Unresectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C1519810
UMLS CUI [1,5]
C3258246
no previous therapy for nsclc is allowed
Description

Non-Small Cell Lung Carcinoma Therapeutic procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332197
age >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bidimensionally measurable disease
Description

Measurable Disease 2-Dimensional

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
performance status (who) 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
absence of pleural effusion
Description

Pleural effusion Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0332197
adequate liver (serum bilirubin < 1.5 times the upper normal limit (unl); ast and alt < 2.5 times the unl in the absence of demonstrable liver metastases, or < 5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0494165
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0494165
UMLS CUI [6,2]
C0150312
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
UMLS CUI [9,1]
C0005953
UMLS CUI [9,2]
C0031843
UMLS CUI [10]
C0200633
UMLS CUI [11]
C0032181
life expectancy of more than 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Description

Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
malnutrition (loss of ≥ 20% of the original body weight)
Description

Malnutrition | Weight decreased Percentage | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0005910
performance status: 3-4
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
sensor or motor neuropathy > grade i
Description

Sensory neuropathy CTCAE Grades | Motor neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235025
UMLS CUI [2,2]
C1516728
second primary malignancy, except for non-melanoma skin cancer
Description

Second Primary Cancers | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0699893
psychiatric illness or social situation that would preclude study compliance
Description

Mental disorder Protocol Compliance Excluded | Social situation Protocol Compliance Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C2828389
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00431613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Local Unresectable TNM clinical staging
Item
histologically or cytologically confirmed, unresectable locally advanced (stage iiia/iiib) nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C3258246 (UMLS CUI [1,5])
Non-Small Cell Lung Carcinoma Therapeutic procedure Absent
Item
no previous therapy for nsclc is allowed
boolean
C0007131 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
WHO performance status scale
Item
performance status (who) 0-2
boolean
C1298650 (UMLS CUI [1])
Pleural effusion Absent
Item
absence of pleural effusion
boolean
C0032227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver Absent | Secondary malignant neoplasm of liver Present | Renal function | Creatinine measurement, serum | Bone Marrow function | Neutrophil count | Platelet Count measurement
Item
adequate liver (serum bilirubin < 1.5 times the upper normal limit (unl); ast and alt < 2.5 times the unl in the absence of demonstrable liver metastases, or < 5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0494165 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0494165 (UMLS CUI [6,1])
C0150312 (UMLS CUI [6,2])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0005953 (UMLS CUI [9,1])
C0031843 (UMLS CUI [9,2])
C0200633 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Malnutrition | Weight decreased Percentage | Body Weight
Item
malnutrition (loss of ≥ 20% of the original body weight)
boolean
C0162429 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005910 (UMLS CUI [3])
performance status
Item
performance status: 3-4
boolean
C1518965 (UMLS CUI [1])
Sensory neuropathy CTCAE Grades | Motor neuropathy CTCAE Grades
Item
sensor or motor neuropathy > grade i
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235025 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Second Primary Cancers | Skin carcinoma
Item
second primary malignancy, except for non-melanoma skin cancer
boolean
C0751623 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Mental disorder Protocol Compliance Excluded | Social situation Protocol Compliance Excluded
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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