ID

23928

Description

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

Keywords

Versions (1)
  1. 7/18/17 7/18/17 -
Uploaded on

July 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Toxicity NCT00531076

English

Eligibility Toxicity NCT00531076

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

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.
Description

ID.2

Data type

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.
Description

ID.3

Data type

boolean

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

ID.4

Data type

boolean

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

ID.5

Data type

boolean

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

ID.6

Data type

boolean

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

ID.7

Data type

boolean

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

ID.8

Data type

boolean

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

ID.9

Data type

boolean

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

ID.10

Data type

boolean

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

ID.11

Data type

boolean

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

ID.12

Data type

boolean

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

ID.13

Data type

boolean

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

ID.14

Data type

boolean

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

ID.15

Data type

boolean

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

ID.16

Data type

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.
Description

ID.17

Data type

boolean

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

ID.18

Data type

boolean

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

ID.19

Data type

boolean

Alias
UMLS CUI [1]
C3714514
Exclusion Criteria
Description

Exclusion Criteria

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

ID.20

Data type

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
Description

ID.21

Data type

boolean

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

ID.22

Data type

boolean

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

ID.23

Data type

boolean

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

ID.24

Data type

boolean

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

ID.25

Data type

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.
Description

ID.26

Data type

boolean

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

ID.27

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Toxicity NCT00531076

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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