ID

23928

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.07.17 18.07.17 -
Hochgeladen am

18. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Toxicity NCT00531076

Englisch

Eligibility Toxicity NCT00531076

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

ID.1

Datentyp

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.
Beschreibung

ID.2

Datentyp

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.
Beschreibung

ID.3

Datentyp

boolean

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

ID.4

Datentyp

boolean

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

ID.5

Datentyp

boolean

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

ID.6

Datentyp

boolean

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

ID.7

Datentyp

boolean

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

ID.8

Datentyp

boolean

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

ID.9

Datentyp

boolean

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

ID.10

Datentyp

boolean

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

ID.11

Datentyp

boolean

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

ID.12

Datentyp

boolean

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

ID.13

Datentyp

boolean

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

ID.14

Datentyp

boolean

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

ID.15

Datentyp

boolean

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

ID.16

Datentyp

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.
Beschreibung

ID.17

Datentyp

boolean

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

ID.18

Datentyp

boolean

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

ID.19

Datentyp

boolean

Alias
UMLS CUI [1]
C3714514
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

ID.20

Datentyp

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
Beschreibung

ID.21

Datentyp

boolean

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

ID.22

Datentyp

boolean

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

ID.23

Datentyp

boolean

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

ID.24

Datentyp

boolean

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

ID.25

Datentyp

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.
Beschreibung

ID.26

Datentyp

boolean

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

ID.27

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Toxicity NCT00531076

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Toxicity NCT00531076
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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