ID

41183

Descripción

Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00104767

Link

https://clinicaltrials.gov/show/NCT00104767

Palabras clave

Versiones (1)
  1. 7/7/20 7/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de julio de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT00104767

Inglés

Eligibility Lung Cancer NCT00104767

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed non-small cell lung cancer
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
stage iiib or iv disease
Descripción

Disease TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
radiographically measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
18 and over
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
performance status: ecog 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
renal: creatinine ≤ 2 mg/dl
Descripción

Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
negative pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Descripción

Females & males of reproductive potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
more than 4 weeks since prior chemotherapy
Descripción

Prior Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
endocrine therapy: more than 4 weeks since prior corticosteroids; no concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids
Descripción

Hormone Therapy | Adrenal Cortex Hormones Previous | Adrenal Cortex Hormones Absent | Adrenal Cortex Hormones chronic Absent | Exception Indication Topical steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3146298
UMLS CUI [5,3]
C2064827
radiotherapy: more than 4 weeks since prior radiotherapy
Descripción

Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
more than 4 weeks since other prior anticancer therapy
Descripción

Cancer treatment Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
more than 4 weeks since prior non-cytotoxic investigational agents
Descripción

Investigational New Drugs Previous | Exception Cytotoxic agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304497
at least 72 hours since prior nonsteroidal anti-inflammatory drugs (nsaids)
Descripción

Anti-Inflammatory Agents, Non-Steroidal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003211
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
Descripción

Comorbidity Excludes Investigational Therapy | Comorbidity Excludes Protocol Compliance | Mental condition Excludes Investigational Therapy | Mental condition Excludes Protocol Compliance | Chronic disease Excludes Investigational Therapy | Chronic disease Excludes Protocol Compliance | Laboratory test result abnormal Excludes Investigational Therapy | Laboratory test result abnormal Excludes Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0949266
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0949266
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0438215
UMLS CUI [7,2]
C0332196
UMLS CUI [7,3]
C0949266
UMLS CUI [8,1]
C0438215
UMLS CUI [8,2]
C0332196
UMLS CUI [8,3]
C0525058
hypersensitivity to celecoxib, sulfonamides, aspirin, other nsaids, or any study reagent
Descripción

Hypersensitivity Celecoxib | Allergy to sulfonamide | Allergy to aspirin | Allergy to non-steroidal anti-inflammatory agent | Hypersensitivity Clinical Trial Reagents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0538927
UMLS CUI [2]
C0038757
UMLS CUI [3]
C0004058
UMLS CUI [4]
C0570537
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0008976
UMLS CUI [5,3]
C0034760
history of gastrointestinal ulceration, bleeding, or perforation
Descripción

Gastrointestinal ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
other concurrent cyclooxygenase-2 or -3 inhibitors
Descripción

Cyclooxygenase 2 Inhibitors | Cox-3 inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1257954
UMLS CUI [2]
C4722121
other concurrent nsaids
Descripción

NSAIDs Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Lung Cancer NCT00104767

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iiib or iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable Disease
Item
radiographically measurable disease
boolean
C1513041 (UMLS CUI [1])
Age
Item
18 and over
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status: ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
renal: creatinine ≤ 2 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Prior Chemotherapy
Item
more than 4 weeks since prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Hormone Therapy | Adrenal Cortex Hormones Previous | Adrenal Cortex Hormones Absent | Adrenal Cortex Hormones chronic Absent | Exception Indication Topical steroids
Item
endocrine therapy: more than 4 weeks since prior corticosteroids; no concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids
boolean
C0279025 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C3146298 (UMLS CUI [5,2])
C2064827 (UMLS CUI [5,3])
Therapeutic radiology procedure
Item
radiotherapy: more than 4 weeks since prior radiotherapy
boolean
C1522449 (UMLS CUI [1])
Cancer treatment Other
Item
more than 4 weeks since other prior anticancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Investigational New Drugs Previous | Exception Cytotoxic agent
Item
more than 4 weeks since prior non-cytotoxic investigational agents
boolean
C0013230 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0304497 (UMLS CUI [2,2])
Anti-Inflammatory Agents, Non-Steroidal
Item
at least 72 hours since prior nonsteroidal anti-inflammatory drugs (nsaids)
boolean
C0003211 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Excludes Investigational Therapy | Comorbidity Excludes Protocol Compliance | Mental condition Excludes Investigational Therapy | Mental condition Excludes Protocol Compliance | Chronic disease Excludes Investigational Therapy | Chronic disease Excludes Protocol Compliance | Laboratory test result abnormal Excludes Investigational Therapy | Laboratory test result abnormal Excludes Protocol Compliance
Item
comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0008679 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0949266 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0438215 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0949266 (UMLS CUI [7,3])
C0438215 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Hypersensitivity Celecoxib | Allergy to sulfonamide | Allergy to aspirin | Allergy to non-steroidal anti-inflammatory agent | Hypersensitivity Clinical Trial Reagents
Item
hypersensitivity to celecoxib, sulfonamides, aspirin, other nsaids, or any study reagent
boolean
C0020517 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
C0038757 (UMLS CUI [2])
C0004058 (UMLS CUI [3])
C0570537 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0008976 (UMLS CUI [5,2])
C0034760 (UMLS CUI [5,3])
Gastrointestinal ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of gastrointestinal ulceration, bleeding, or perforation
boolean
C0237938 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Cyclooxygenase 2 Inhibitors | Cox-3 inhibitor
Item
other concurrent cyclooxygenase-2 or -3 inhibitors
boolean
C1257954 (UMLS CUI [1])
C4722121 (UMLS CUI [2])
NSAIDs Other
Item
other concurrent nsaids
boolean
C0003211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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