ID

23928

Descripción

Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00531076

Link

https://clinicaltrials.gov/show/NCT00531076

Palabras clave

Versiones (1)
  1. 18/7/17 18/7/17 -
Subido en

18 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Toxicity NCT00531076

Inglés

Eligibility Toxicity NCT00531076

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cytologically or histologically confirmed stages ii or iii non-squamous nsclc
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C2585890
2. no evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization.
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C1272790
3. no prior systemic therapy for nsclc. prior surgery and/or extra-thoracic irradiation is permitted.
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1515119
4. presence of at least one measurable target lesion
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2986546
5. age 18 or greater.
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
6. who performance status of 0 or 1.
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
7. acceptable pulmonary function as defined by a fev1 of ≥30% and a dlco of ≥40% of predicted
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231921
8. life expectancy of at least 12 weeks.
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
9. adequate hematological, renal and hepatic functions
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0232804
absolute neutrophil count >2x109/l.
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100x109/l.
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin < 1.5 x unl
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005437
asat/alat < 2 x unl
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
alkaline phosphatase < 5 x unl
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002059
creatinine < 130 μmol/l
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0010294
creatinine clearance > 60 ml/min; measured or calculated
Descripción

ID.16

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
10. urine dipstick for proteinuria < 1+. if urine dipstick is ≥ 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.
Descripción

ID.17

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033687
11. no pre-existing sensory neurotoxicity grade 2 (ctc)
Descripción

ID.18

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235032
12. no active (uncontrolled) infection requiring antibiotics
Descripción

ID.19

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3714514
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. mixed tumor types with small cell lung cancer or squamous cell carcinoma
Descripción

ID.20

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1368354
2. other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
Descripción

ID.21

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
3. serious non-healing wound or ulcer.
Descripción

ID.22

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0041582
4. asat and alat > 1,5 x unl
Descripción

ID.23

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
5. alkaline phosphatase 5 x unl
Descripción

ID.24

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002059
6. evidence of bleeding diathesis or coagulopathy.
Descripción

ID.25

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005779
7. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
Descripción

ID.26

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
8. participation in other trial with investigational drug or treatment modality.
Descripción

ID.27

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Toxicity NCT00531076

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. cytologically or histologically confirmed stages ii or iii non-squamous nsclc
boolean
C0007131 (UMLS CUI [1,1])
C2585890 (UMLS CUI [1,2])
ID.2
Item
2. no evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization.
boolean
C0019079 (UMLS CUI [1,1])
C1272790 (UMLS CUI [1,2])
ID.3
Item
3. no prior systemic therapy for nsclc. prior surgery and/or extra-thoracic irradiation is permitted.
boolean
C1515119 (UMLS CUI [1])
ID.4
Item
4. presence of at least one measurable target lesion
boolean
C2986546 (UMLS CUI [1])
ID.5
Item
5. age 18 or greater.
boolean
C0001779 (UMLS CUI [1])
ID.6
Item
6. who performance status of 0 or 1.
boolean
C1298650 (UMLS CUI [1])
ID.7
Item
7. acceptable pulmonary function as defined by a fev1 of ≥30% and a dlco of ≥40% of predicted
boolean
C0231921 (UMLS CUI [1])
ID.8
Item
8. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ID.9
Item
9. adequate hematological, renal and hepatic functions
boolean
C0232741 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
ID.10
Item
absolute neutrophil count >2x109/l.
boolean
C0948762 (UMLS CUI [1])
ID.11
Item
platelet count > 100x109/l.
boolean
C0032181 (UMLS CUI [1])
ID.12
Item
total bilirubin < 1.5 x unl
boolean
C0005437 (UMLS CUI [1])
ID.13
Item
asat/alat < 2 x unl
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
ID.14
Item
alkaline phosphatase < 5 x unl
boolean
C0002059 (UMLS CUI [1])
ID.15
Item
creatinine < 130 μmol/l
boolean
C0010294 (UMLS CUI [1])
ID.16
Item
creatinine clearance > 60 ml/min; measured or calculated
boolean
C0373595 (UMLS CUI [1])
ID.17
Item
10. urine dipstick for proteinuria < 1+. if urine dipstick is ≥ 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.
boolean
C0033687 (UMLS CUI [1])
ID.18
Item
11. no pre-existing sensory neurotoxicity grade 2 (ctc)
boolean
C0235032 (UMLS CUI [1])
ID.19
Item
12. no active (uncontrolled) infection requiring antibiotics
boolean
C3714514 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.20
Item
1. mixed tumor types with small cell lung cancer or squamous cell carcinoma
boolean
C1368354 (UMLS CUI [1])
ID.21
Item
2. other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension
boolean
C0012634 (UMLS CUI [1])
ID.22
Item
3. serious non-healing wound or ulcer.
boolean
C0750433 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
ID.23
Item
4. asat and alat > 1,5 x unl
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
ID.24
Item
5. alkaline phosphatase 5 x unl
boolean
C0002059 (UMLS CUI [1])
ID.25
Item
6. evidence of bleeding diathesis or coagulopathy.
boolean
C0005779 (UMLS CUI [1])
ID.26
Item
7. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
boolean
C1321605 (UMLS CUI [1])
ID.27
Item
8. participation in other trial with investigational drug or treatment modality.
boolean
C0013230 (UMLS CUI [1])
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