ID

31120

Descripción

Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00687817

Link

https://clinicaltrials.gov/show/NCT00687817

Palabras clave

Versiones (1)
  1. 21/7/18 21/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

21 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00687817

Inglés

Eligibility Non-small Cell Lung Cancer NCT00687817

1 formularios  
Criteria
Descripción

Criteria

adults over age 18 years of age with a life expectancy of at least 3 months
Descripción

Adult | Age | Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
histologically or cytologically confirmed non-small cell lung cancer at stage iiib (with pleural effusion), stage iv, or recurrence
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion | Non-small cell lung cancer recurrent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0278517
measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral ct)
Descripción

Measurable Disease Cross-sectional imaging | Longest Diameter | Longest Diameter Spiral CT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3824793
UMLS CUI [2]
C0552406
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0860888
adequate hematologic (anc ≥ 1500 cells/µl; hemoglobin ≥9 g/dl; platelets ≥100,000/µl and ≤500,000/µl ), renal (serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min), and hepatic function (bilirubin ≤ 1.5 x uln, alt ≤ 3 x uln, ast ≤ 3 x uln)
Descripción

Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
UMLS CUI [7]
C2711451
UMLS CUI [8]
C0232741
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0201899
d-dimer ≤ 2 x uln
Descripción

D-Dimer Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826333
key exclusion criteria:
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
small cell or mixed histology
Descripción

Cells Small Histology | Histology Mixed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0700321
UMLS CUI [1,3]
C4048239
UMLS CUI [2,1]
C4048239
UMLS CUI [2,2]
C0205430
known history of bleeding diathesis or coagulopathy
Descripción

Bleeding tendency | Blood Coagulation Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gi bleeding
Descripción

Hemorrhage | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0473237
UMLS CUI [3]
C0019079
UMLS CUI [4]
C0017181
any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
Descripción

Thromboembolism | Deep Vein Thrombosis | Pulmonary Thromboembolisms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0524702
prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
Descripción

Prior Chemotherapy Area Measurable Disease | Prior Immunotherapy Area Measurable Disease | Prior radiation therapy Area Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C1513041
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205146
UMLS CUI [3,3]
C1513041
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0277556
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C1522449
radiotherapy within 2 weeks preceding study day 1
Descripción

Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
symptomatic or clinically active cns disease or metastatic lesions
Descripción

CNS disorder Symptomatic | CNS disorder | Metastatic Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0007682
UMLS CUI [3]
C1513183
major surgery within 4 weeks of study day 1
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
Descripción

Comorbidity Uncontrolled | Diabetes Mellitus | Hypertensive disease | Thyroid Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0040128
any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
Descripción

Angina Pectoris | Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
a history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. anti-platelet agents are prohibited during the study.
Descripción

Condition Requirement Antiplatelet therapy | Exception Aspirin Cardiovascular event prophylaxis | Antiplatelet Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1096021
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004057
UMLS CUI [2,3]
C1610618
UMLS CUI [3]
C0085826
requirement for chronic daily treatment with nsaids, anti-platelet drugs, or steroids
Descripción

Non-Steroidal Anti-Inflammatory Agents Daily chronic | Antiplatelet Agents Daily chronic | Steroids Daily chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0085826
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0205191
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00687817

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Adult | Age | Life Expectancy
Item
adults over age 18 years of age with a life expectancy of at least 3 months
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion | Non-small cell lung cancer recurrent
Item
histologically or cytologically confirmed non-small cell lung cancer at stage iiib (with pleural effusion), stage iv, or recurrence
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0278517 (UMLS CUI [3])
Measurable Disease Cross-sectional imaging | Longest Diameter | Longest Diameter Spiral CT
Item
measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral ct)
boolean
C1513041 (UMLS CUI [1,1])
C3824793 (UMLS CUI [1,2])
C0552406 (UMLS CUI [2])
C0552406 (UMLS CUI [3,1])
C0860888 (UMLS CUI [3,2])
Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
adequate hematologic (anc ≥ 1500 cells/µl; hemoglobin ≥9 g/dl; platelets ≥100,000/µl and ≤500,000/µl ), renal (serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min), and hepatic function (bilirubin ≤ 1.5 x uln, alt ≤ 3 x uln, ast ≤ 3 x uln)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C2711451 (UMLS CUI [7])
C0232741 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
D-Dimer Measurement
Item
d-dimer ≤ 2 x uln
boolean
C2826333 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cells Small Histology | Histology Mixed
Item
small cell or mixed histology
boolean
C0007634 (UMLS CUI [1,1])
C0700321 (UMLS CUI [1,2])
C4048239 (UMLS CUI [1,3])
C4048239 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
Bleeding tendency | Blood Coagulation Disorder
Item
known history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Hemorrhage | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage
Item
any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gi bleeding
boolean
C0019080 (UMLS CUI [1])
C0473237 (UMLS CUI [2])
C0019079 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
Thromboembolism | Deep Vein Thrombosis | Pulmonary Thromboembolisms
Item
any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
boolean
C0040038 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0524702 (UMLS CUI [3])
Prior Chemotherapy Area Measurable Disease | Prior Immunotherapy Area Measurable Disease | Prior radiation therapy Area Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure
Item
prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
boolean
C1514457 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1514461 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0205146 (UMLS CUI [3,2])
C1513041 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0277556 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C1522449 (UMLS CUI [4,4])
Therapeutic radiology procedure
Item
radiotherapy within 2 weeks preceding study day 1
boolean
C1522449 (UMLS CUI [1])
CNS disorder Symptomatic | CNS disorder | Metastatic Lesion
Item
symptomatic or clinically active cns disease or metastatic lesions
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2])
C1513183 (UMLS CUI [3])
Major surgery
Item
major surgery within 4 weeks of study day 1
boolean
C0679637 (UMLS CUI [1])
Comorbidity Uncontrolled | Diabetes Mellitus | Hypertensive disease | Thyroid Diseases
Item
uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
Angina Pectoris | Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack
Item
any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
boolean
C0002962 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Condition Requirement Antiplatelet therapy | Exception Aspirin Cardiovascular event prophylaxis | Antiplatelet Agents
Item
a history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. anti-platelet agents are prohibited during the study.
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1096021 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1610618 (UMLS CUI [2,3])
C0085826 (UMLS CUI [3])
Non-Steroidal Anti-Inflammatory Agents Daily chronic | Antiplatelet Agents Daily chronic | Steroids Daily chronic
Item
requirement for chronic daily treatment with nsaids, anti-platelet drugs, or steroids
boolean
C0003211 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0085826 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0038317 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
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