ID

41186

Descripción

Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01503385

Link

https://clinicaltrials.gov/show/NCT01503385

Palabras clave

Versiones (1)
  1. 8/7/20 8/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de julio de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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Eligibility Lung Cancer NCT01503385

Inglés

Eligibility Lung Cancer NCT01503385

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
• 18-70 years old, male or female
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
histological or cytological evidence of nsclc.
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
unresectable stage iii nsclc.
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging Unresectable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1519810
karnofsky score: at least 70.
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
estimated survival: at least 6 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
not receiving radiotherapy or combined modality therapy to treat another malignancy.
Descripción

Therapeutic radiology procedure Absent Cancer Other | Combined Modality Therapy Absent Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1707251
UMLS CUI [2,1]
C0009429
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1707251
no history of active gastric ulcer, active gi bleeding, or renal failure.
Descripción

Gastric ulcer Absent | Gastrointestinal Hemorrhage Absent | Kidney Failure Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038358
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C0332197
no severe hypertension, cardiac disease, or diabetes mellitus
Descripción

Severe hypertension Absent | Heart Disease Absent | Diabetes Mellitus Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0332197
normal blood routine and chemical tests
Descripción

Hematologic Tests Normal | Chemical procedure Normal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0201682
UMLS CUI [2,2]
C0205307
patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Descripción

Informed Consent | Informed Consent Guardian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
• other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
Descripción

Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
extensive distant metastases
Descripción

Distant metastasis Extensive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0205231
pregnancy or in lactation
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
allergic to sulfonamides, nsaids or celebrex
Descripción

Allergy to sulfonamide | Allergy to nonsteroidal anti-inflammatory agents | Hypersensitivity Celebrex

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2]
C0746949
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0719198
routine use of nsaids such as high dose of aspirin
Descripción

NSAIDs Regular | Aspirin High dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0444956
history of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.
Descripción

Cardiovascular Diseases | Myocardial Infarction | Angina Pectoris | Coronary angioplasty | Congestive heart failure | Cerebrovascular accident | Coronary Artery Bypass Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0190211
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0010055
abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein s or c deficiencies, prior heparin-induced thrombocytopenia, factor v leiden deficiencies or high homocysteine levels.
Descripción

Blood Coagulation Disorders | Deep Vein Thrombosis | Pulmonary Embolism | Lupus Erythematosus, Systemic | Family history of protein S deficiency | Family history of protein C deficiency | Heparin-induced thrombocytopenia | Factor v leiden deficiency | Serum homocysteine increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
UMLS CUI [4]
C0024141
UMLS CUI [5]
C4038972
UMLS CUI [6]
C4040893
UMLS CUI [7]
C0272285
UMLS CUI [8]
C0920099
UMLS CUI [9]
C0877580
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Similar models

Eligibility Lung Cancer NCT01503385

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
• 18-70 years old, male or female
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
histological or cytological evidence of nsclc.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging Unresectable
Item
unresectable stage iii nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
karnofsky score: at least 70.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
estimated survival: at least 6 months
boolean
C0023671 (UMLS CUI [1])
Therapeutic radiology procedure Absent Cancer Other | Combined Modality Therapy Absent Cancer Other
Item
not receiving radiotherapy or combined modality therapy to treat another malignancy.
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1707251 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1707251 (UMLS CUI [2,3])
Gastric ulcer Absent | Gastrointestinal Hemorrhage Absent | Kidney Failure Absent
Item
no history of active gastric ulcer, active gi bleeding, or renal failure.
boolean
C0038358 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035078 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Severe hypertension Absent | Heart Disease Absent | Diabetes Mellitus Absent
Item
no severe hypertension, cardiac disease, or diabetes mellitus
boolean
C4013784 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hematologic Tests Normal | Chemical procedure Normal
Item
normal blood routine and chemical tests
boolean
C0018941 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0201682 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Informed Consent | Informed Consent Guardian
Item
patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
• other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Distant metastasis Extensive
Item
extensive distant metastases
boolean
C1269798 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or in lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Allergy to sulfonamide | Allergy to nonsteroidal anti-inflammatory agents | Hypersensitivity Celebrex
Item
allergic to sulfonamides, nsaids or celebrex
boolean
C0038757 (UMLS CUI [1])
C0746949 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0719198 (UMLS CUI [3,2])
NSAIDs Regular | Aspirin High dose
Item
routine use of nsaids such as high dose of aspirin
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0004057 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
Cardiovascular Diseases | Myocardial Infarction | Angina Pectoris | Coronary angioplasty | Congestive heart failure | Cerebrovascular accident | Coronary Artery Bypass Surgery
Item
history of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0190211 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
Blood Coagulation Disorders | Deep Vein Thrombosis | Pulmonary Embolism | Lupus Erythematosus, Systemic | Family history of protein S deficiency | Family history of protein C deficiency | Heparin-induced thrombocytopenia | Factor v leiden deficiency | Serum homocysteine increased
Item
abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein s or c deficiencies, prior heparin-induced thrombocytopenia, factor v leiden deficiencies or high homocysteine levels.
boolean
C0005779 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C4038972 (UMLS CUI [5])
C4040893 (UMLS CUI [6])
C0272285 (UMLS CUI [7])
C0920099 (UMLS CUI [8])
C0877580 (UMLS CUI [9])
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