ID

38395

Descripción

Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01494415

Link

https://clinicaltrials.gov/show/NCT01494415

Palabras clave

Versiones (1)
  1. 16/10/19 16/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01494415

Inglés

Eligibility Carcinoma, Non-Small-Cell Lung NCT01494415

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
previously untreated, histological documented, inoperable stage iiia or iiib squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
Descripción

Squamous cell carcinoma of lung Untreated Inoperable TNM clinical staging | Pericardial effusion Excluded | Pleural effusion Excluded | Hilar lymph nodes Contralateral Excluded | Supraclavicular lymph nodes Contralateral Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149782
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0205187
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0032227
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C1305372
UMLS CUI [4,2]
C0441988
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0229730
UMLS CUI [5,2]
C0441988
UMLS CUI [5,3]
C0332196
patients must have measurable disease according to recist criteria, and all detectable tumor can be encompassed by radiation therapy fields.
Descripción

Measurable Disease | Neoplasm Appropriate Radiation Field

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1882536
weight loss ≦ 5% in the previous six months.
Descripción

Weight loss Percentage Timespan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
Descripción

Hematologic function | Liver function | Pulmonary function | Renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0231921
UMLS CUI [4]
C0232804
female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
Descripción

Childbearing Potential Serum pregnancy test negative | Gender Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
patients must sign a study-specific informed consent form prior to study entry.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
Descripción

Complete excision Neoplasm | Recurrent disease | Eligibility Operative Surgical Procedure Definitive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0027651
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0443196
previous chemotherapy or previous biologic response modifiers for current lung cancer.
Descripción

Prior Chemotherapy Carcinoma of lung | Biological Response Modifiers Carcinoma of lung

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0684249
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0684249
patient has previously had thoracic radiation therapy.
Descripción

Radiotherapy to thorax

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4038705
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
Descripción

Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
Descripción

Comorbidity Serious compromises Patient safety | Comorbidity Serious compromises Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C2732579
history of significant neurological or mental disorder, including seizures or dementia.
Descripción

Nervous system disorder | Mental disorders | Seizures | Dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0497327
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01494415

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale.
boolean
C1520224 (UMLS CUI [1])
Squamous cell carcinoma of lung Untreated Inoperable TNM clinical staging | Pericardial effusion Excluded | Pleural effusion Excluded | Hilar lymph nodes Contralateral Excluded | Supraclavicular lymph nodes Contralateral Excluded
Item
previously untreated, histological documented, inoperable stage iiia or iiib squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
boolean
C0149782 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0031039 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1305372 (UMLS CUI [4,1])
C0441988 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0229730 (UMLS CUI [5,1])
C0441988 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
Measurable Disease | Neoplasm Appropriate Radiation Field
Item
patients must have measurable disease according to recist criteria, and all detectable tumor can be encompassed by radiation therapy fields.
boolean
C1513041 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1882536 (UMLS CUI [2,3])
Weight loss Percentage Timespan
Item
weight loss ≦ 5% in the previous six months.
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Hematologic function | Liver function | Pulmonary function | Renal function
Item
patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
Childbearing Potential Serum pregnancy test negative | Gender Contraceptive methods
Item
female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
patients must sign a study-specific informed consent form prior to study entry.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Complete excision Neoplasm | Recurrent disease | Eligibility Operative Surgical Procedure Definitive
Item
complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
boolean
C0015250 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1548635 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0443196 (UMLS CUI [3,3])
Prior Chemotherapy Carcinoma of lung | Biological Response Modifiers Carcinoma of lung
Item
previous chemotherapy or previous biologic response modifiers for current lung cancer.
boolean
C1514457 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0684249 (UMLS CUI [2,2])
Radiotherapy to thorax
Item
patient has previously had thoracic radiation therapy.
boolean
C4038705 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma | Exception Disease Free Duration
Item
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Comorbidity Serious compromises Patient safety | Comorbidity Serious compromises Completion of clinical trial
Item
serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2732579 (UMLS CUI [2,4])
Nervous system disorder | Mental disorders | Seizures | Dementia
Item
history of significant neurological or mental disorder, including seizures or dementia.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
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