ID

36635

Descripción

Hypofractionated Accelerated Radiotherapy With Concomitant Chemotherapy for NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02367443

Link

https://clinicaltrials.gov/show/NCT02367443

Palabras clave

Versiones (1)
  1. 27/5/19 27/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02367443

Inglés

Eligibility Non-small Cell Lung Cancer NCT02367443

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
• pathological or cytological confirmation of the diagnosis of nsclc
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
confirmation of clinical stage iii based on: clinical examination, ct of the chest and abdomen (pet-ct highly recommended), bronchoscopy, ct or mri of the brain if suspicion of brain metastases
Descripción

TNM clinical staging Clinical examination | TNM clinical staging CT of chest and abdomen | PET/CT scan Recommended | TNM clinical staging Bronchoscopy | Suspicion Metastatic malignant neoplasm to brain | CT scan brain | MRI scan brain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C1456356
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C1630402
UMLS CUI [3,1]
C1699633
UMLS CUI [3,2]
C0034866
UMLS CUI [4,1]
C3258246
UMLS CUI [4,2]
C0006290
UMLS CUI [5,1]
C0242114
UMLS CUI [5,2]
C0220650
UMLS CUI [6]
C0412585
UMLS CUI [7]
C0412675
no abnormalities in blood count precluding administration of full doses of cisplatin and vinorelbine (neutrophils ≥1.5x109/l; platelets ≥100 x109/l; hemoglobin >11 g/dl)
Descripción

Blood count normal | Cisplatin Dose Full | Vinorelbine Dose Full | Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1535969
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0443225
UMLS CUI [3,1]
C0078257
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0443225
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0518015
no abnormalities in renal and hepatic function precluding administration of full doses of cisplatin and vinorelbine (creatinine clearance >50 ml/minute, aminotransferases < 1.5 of upper limit of normal value)
Descripción

Renal function | Liver function | Cisplatin Dose Full | Vinorelbine Dose Full | Creatinine clearance measurement | Transaminases Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0008838
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0443225
UMLS CUI [4,1]
C0078257
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0443225
UMLS CUI [5]
C0373595
UMLS CUI [6,1]
C0002594
UMLS CUI [6,2]
C0242485
age <75
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
kps: 80-100
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
fev1 > 1 liter (except cases with very low body surface, when fev1 should be >40%)
Descripción

FEV1 | Exception Body Surface Area Very low

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0849974
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005902
UMLS CUI [2,3]
C0442811
no chronic diseases causing contraindication to the use of cht
Descripción

Chronic disease Absent | Etiology aspects Medical contraindication Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0392920
no previous rt on the thoracic region
Descripción

Radiotherapy to thorax Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332197
informed consent of patient for the participation in the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
lack of meeting all inclusion criteria
Descripción

Inclusion criteria Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0332268
presence of clinically examined supraclavicular lymph nodes
Descripción

Lymph node positive supraclavicular Clinical examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0746319
UMLS CUI [1,2]
C0446461
UMLS CUI [1,3]
C1456356
malignant pleural or pericardial effusion
Descripción

Pleural Effusion, Malignant | Malignant pericardial effusion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0080032
UMLS CUI [2]
C0220655
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02367443

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
• pathological or cytological confirmation of the diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging Clinical examination | TNM clinical staging CT of chest and abdomen | PET/CT scan Recommended | TNM clinical staging Bronchoscopy | Suspicion Metastatic malignant neoplasm to brain | CT scan brain | MRI scan brain
Item
confirmation of clinical stage iii based on: clinical examination, ct of the chest and abdomen (pet-ct highly recommended), bronchoscopy, ct or mri of the brain if suspicion of brain metastases
boolean
C3258246 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2,1])
C1630402 (UMLS CUI [2,2])
C1699633 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4,1])
C0006290 (UMLS CUI [4,2])
C0242114 (UMLS CUI [5,1])
C0220650 (UMLS CUI [5,2])
C0412585 (UMLS CUI [6])
C0412675 (UMLS CUI [7])
Blood count normal | Cisplatin Dose Full | Vinorelbine Dose Full | Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
no abnormalities in blood count precluding administration of full doses of cisplatin and vinorelbine (neutrophils ≥1.5x109/l; platelets ≥100 x109/l; hemoglobin >11 g/dl)
boolean
C1535969 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443225 (UMLS CUI [2,3])
C0078257 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443225 (UMLS CUI [3,3])
C0200633 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
Renal function | Liver function | Cisplatin Dose Full | Vinorelbine Dose Full | Creatinine clearance measurement | Transaminases Measurement
Item
no abnormalities in renal and hepatic function precluding administration of full doses of cisplatin and vinorelbine (creatinine clearance >50 ml/minute, aminotransferases < 1.5 of upper limit of normal value)
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0008838 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443225 (UMLS CUI [3,3])
C0078257 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0443225 (UMLS CUI [4,3])
C0373595 (UMLS CUI [5])
C0002594 (UMLS CUI [6,1])
C0242485 (UMLS CUI [6,2])
Age
Item
age <75
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps: 80-100
boolean
C0206065 (UMLS CUI [1])
FEV1 | Exception Body Surface Area Very low
Item
fev1 > 1 liter (except cases with very low body surface, when fev1 should be >40%)
boolean
C0849974 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005902 (UMLS CUI [2,2])
C0442811 (UMLS CUI [2,3])
Chronic disease Absent | Etiology aspects Medical contraindication Chemotherapy
Item
no chronic diseases causing contraindication to the use of cht
boolean
C0008679 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Radiotherapy to thorax Absent
Item
no previous rt on the thoracic region
boolean
C4038705 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
informed consent of patient for the participation in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Lacking
Item
lack of meeting all inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Lymph node positive supraclavicular Clinical examination
Item
presence of clinically examined supraclavicular lymph nodes
boolean
C0746319 (UMLS CUI [1,1])
C0446461 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
Pleural Effusion, Malignant | Malignant pericardial effusion
Item
malignant pleural or pericardial effusion
boolean
C0080032 (UMLS CUI [1])
C0220655 (UMLS CUI [2])
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