ID

30268

Descripción

Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00852644

Link

https://clinicaltrials.gov/show/NCT00852644

Palabras clave

Versiones (1)
  1. 26/5/18 26/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00852644

Inglés

Eligibility Lung Cancer NCT00852644

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease characteristics:
Descripción

Disease characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0599878
histologically confirmed non-small cell lung cancer
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
stage i or ii disease (t1-3, n0, m0)
Descripción

Disease TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
t2 or t3 tumor ≤ 5 cm
Descripción

Tumor Size TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C3258246
no t3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Descripción

Exclusion Criteria | Tumor TNM clinical staging Involvement with Chest Central | Tumor TNM clinical staging Involvement with Mediastinum | Involvement with Chest wall allowed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C3258246
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0817096
UMLS CUI [2,5]
C0205099
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C3258246
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0025066
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0205076
UMLS CUI [4,3]
C0683607
tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, and patient deemed "medically inoperable"
Descripción

Tumor Resectable | Patient assessment Inoperable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0679830
UMLS CUI [2,2]
C0205187
patients with fdg-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm n0 status
Descripción

FDG Avidity Mediastinal lymph nodes | Ability Mediastinoscopy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0046056
UMLS CUI [1,2]
C1510996
UMLS CUI [1,3]
C0588055
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0025065
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
not pregnant or nursing
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
no history of contrast allergy
Descripción

Contrast media allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0570562
no psychological issues that would preclude the completion of study treatment
Descripción

Mental problem Excludes Treatment completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0848067
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0580352
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
no prior radiotherapy or chemotherapy
Descripción

Therapeutic radiology procedure | Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
no suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose f 18 [fdg]-avid or measure > 1 cm in short axis diameter on ct scan)
Descripción

Secondary malignant neoplasm of lymph node Suspected | Mediastinoscopy Unsuccessful | Hilar lymph node FDG Avidity | Mediastinal lymph nodes FDG Avidity | Hilar lymph node Diameter Size CT scan | Mediastinal lymph nodes Diameter Size CT scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0025065
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C1305372
UMLS CUI [3,2]
C0046056
UMLS CUI [3,3]
C1510996
UMLS CUI [4,1]
C0588055
UMLS CUI [4,2]
C0046056
UMLS CUI [4,3]
C1510996
UMLS CUI [5,1]
C1305372
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C0456389
UMLS CUI [5,4]
C0040405
UMLS CUI [6,1]
C0588055
UMLS CUI [6,2]
C1301886
UMLS CUI [6,3]
C0456389
UMLS CUI [6,4]
C0040405
no tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Descripción

Neoplasm Bronchial tree | Tumor Volume Bronchial tree Proximal | Neoplasm Carina | Neoplasm of right main stem bronchus | Neoplasm of left main stem bronchus | Neoplasm of bronchus of right upper lobe | Neoplasm of bronchus of left upper lobe | Neoplasm Interlobar bronchus | Neoplasm of bronchus of right middle lobe | Neoplasm lingular bronchus | Neoplasm of bronchus of right lower lobe | Neoplasm of bronchus of left lower lobe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0819141
UMLS CUI [2,1]
C0475276
UMLS CUI [2,2]
C0819141
UMLS CUI [2,3]
C0205107
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1278906
UMLS CUI [4]
C2063962
UMLS CUI [5]
C2063967
UMLS CUI [6]
C1290359
UMLS CUI [7]
C1290360
UMLS CUI [8,1]
C0027651
UMLS CUI [8,2]
C0502383
UMLS CUI [9]
C1290361
UMLS CUI [10,1]
C0027651
UMLS CUI [10,2]
C1280914
UMLS CUI [11]
C1290362
UMLS CUI [12]
C1290363
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Similar models

Eligibility Lung Cancer NCT00852644

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Disease characteristics
Item
disease characteristics:
boolean
C0599878 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
histologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage i or ii disease (t1-3, n0, m0)
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Tumor Size TNM clinical staging
Item
t2 or t3 tumor ≤ 5 cm
boolean
C0027651 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Exclusion Criteria | Tumor TNM clinical staging Involvement with Chest Central | Tumor TNM clinical staging Involvement with Mediastinum | Involvement with Chest wall allowed
Item
no t3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
boolean
C0680251 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0817096 (UMLS CUI [2,4])
C0205099 (UMLS CUI [2,5])
C0027651 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0025066 (UMLS CUI [3,4])
C1314939 (UMLS CUI [4,1])
C0205076 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Tumor Resectable | Patient assessment Inoperable
Item
tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, and patient deemed "medically inoperable"
boolean
C0027651 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0679830 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
FDG Avidity Mediastinal lymph nodes | Ability Mediastinoscopy
Item
patients with fdg-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm n0 status
boolean
C0046056 (UMLS CUI [1,1])
C1510996 (UMLS CUI [1,2])
C0588055 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C0025065 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Contrast media allergy
Item
no history of contrast allergy
boolean
C0570562 (UMLS CUI [1])
Mental problem Excludes Treatment completion
Item
no psychological issues that would preclude the completion of study treatment
boolean
C0848067 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0580352 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Therapeutic radiology procedure | Chemotherapy
Item
no prior radiotherapy or chemotherapy
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Secondary malignant neoplasm of lymph node Suspected | Mediastinoscopy Unsuccessful | Hilar lymph node FDG Avidity | Mediastinal lymph nodes FDG Avidity | Hilar lymph node Diameter Size CT scan | Mediastinal lymph nodes Diameter Size CT scan
Item
no suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose f 18 [fdg]-avid or measure > 1 cm in short axis diameter on ct scan)
boolean
C0686619 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0025065 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C1305372 (UMLS CUI [3,1])
C0046056 (UMLS CUI [3,2])
C1510996 (UMLS CUI [3,3])
C0588055 (UMLS CUI [4,1])
C0046056 (UMLS CUI [4,2])
C1510996 (UMLS CUI [4,3])
C1305372 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C0456389 (UMLS CUI [5,3])
C0040405 (UMLS CUI [5,4])
C0588055 (UMLS CUI [6,1])
C1301886 (UMLS CUI [6,2])
C0456389 (UMLS CUI [6,3])
C0040405 (UMLS CUI [6,4])
Neoplasm Bronchial tree | Tumor Volume Bronchial tree Proximal | Neoplasm Carina | Neoplasm of right main stem bronchus | Neoplasm of left main stem bronchus | Neoplasm of bronchus of right upper lobe | Neoplasm of bronchus of left upper lobe | Neoplasm Interlobar bronchus | Neoplasm of bronchus of right middle lobe | Neoplasm lingular bronchus | Neoplasm of bronchus of right lower lobe | Neoplasm of bronchus of left lower lobe
Item
no tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
boolean
C0027651 (UMLS CUI [1,1])
C0819141 (UMLS CUI [1,2])
C0475276 (UMLS CUI [2,1])
C0819141 (UMLS CUI [2,2])
C0205107 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C1278906 (UMLS CUI [3,2])
C2063962 (UMLS CUI [4])
C2063967 (UMLS CUI [5])
C1290359 (UMLS CUI [6])
C1290360 (UMLS CUI [7])
C0027651 (UMLS CUI [8,1])
C0502383 (UMLS CUI [8,2])
C1290361 (UMLS CUI [9])
C0027651 (UMLS CUI [10,1])
C1280914 (UMLS CUI [10,2])
C1290362 (UMLS CUI [11])
C1290363 (UMLS CUI [12])
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