ID

16672

Beskrivning

Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20); ODM derived from: https://clinicaltrials.gov/show/NCT00310232

Länk

https://clinicaltrials.gov/show/NCT00310232

Nyckelord

Versioner (1)
  1. 2016-07-31 2016-07-31 -
Uppladdad den

31 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Carcinoma NCT00310232

Engelsk

Eligibility Non-Small-Cell Lung Carcinoma NCT00310232

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage iii or iv, or recurrent disease; and
Beskrivning

nsclc stage III or IV

Datatyp

boolean

Alias
UMLS CUI [1]
C0278506
UMLS CUI [2]
C0278987
UMLS CUI [3]
C0278517
2. hemoglobin level at or below 120 g/l; and
Beskrivning

hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
3. at least 18 years of age;
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
Beskrivning

systemic platinum-based chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2266918
2. patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence;
Beskrivning

previous RTx or surgery, no evidenc of disease recurrence

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C0744961
UMLS CUI [3]
C0277556
3. planned high dose thoracic radiation therapy (>10 fractions);
Beskrivning

planned high dose thoracic radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514710
4. a clinically active malignancy, other than the underlying lung cancer which is expected to influence qol;
Beskrivning

clinically active malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
5. expected survival of three months or less;
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. ecog performance status of 3 or 4 (see appendix d);
Beskrivning

ecog performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
7. multiple cns metastasis or a single cns lesion that does not demonstrate radiographic stability (screening ct of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
Beskrivning

cns metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
8. blood transfusions within the last 14 days;
Beskrivning

blood transfusions

Datatyp

boolean

Alias
UMLS CUI [1]
C0005841
9. previous use of erythropoietin;
Beskrivning

previous use of erythropoietin

Datatyp

boolean

Alias
UMLS CUI [1]
C0199970
10. anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
Beskrivning

anemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
11. evidence of untreated folate or vitamin b12 deficiency;
Beskrivning

evidence of untreated folate or vitamin b12 deficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0042847
UMLS CUI [2]
C0016412
12. history of uncontrolled hypertension or diastolic blood pressure greater than 100 mm hg;
Beskrivning

uncontrolled hypertension or diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0235222
13. history of seizure disorder;
Beskrivning

seizure disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
14. known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
Beskrivning

hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
15. pregnancy, lactation or parturition within the previous 30 days;
Beskrivning

pregnancy, lactation or parturition

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1148523
16. unwillingness or inability to complete the required qol questionnaires;
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
17. mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
Beskrivning

condition precluding study compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
18. geographically inaccessible for treatment or follow-up evaluations;
Beskrivning

geographically inaccessible for treatment or follow-up evaluations

Datatyp

boolean

Alias
UMLS CUI [1]
C0814423
19. currently enrolled in an ongoing therapeutic study;
Beskrivning

study participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Non-Small-Cell Lung Carcinoma NCT00310232

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
nsclc stage III or IV
Item
1. histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage iii or iv, or recurrent disease; and
boolean
C0278506 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
C0278517 (UMLS CUI [3])
hemoglobin
Item
2. hemoglobin level at or below 120 g/l; and
boolean
C0518015 (UMLS CUI [1])
age
Item
3. at least 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
systemic platinum-based chemotherapy
Item
1. systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;
boolean
C0392920 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])
previous RTx or surgery, no evidenc of disease recurrence
Item
2. patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence;
boolean
C0279134 (UMLS CUI [1])
C0744961 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
planned high dose thoracic radiation therapy
Item
3. planned high dose thoracic radiation therapy (>10 fractions);
boolean
C1514710 (UMLS CUI [1])
clinically active malignancy
Item
4. a clinically active malignancy, other than the underlying lung cancer which is expected to influence qol;
boolean
C0006826 (UMLS CUI [1])
life expectancy
Item
5. expected survival of three months or less;
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
6. ecog performance status of 3 or 4 (see appendix d);
boolean
C1520224 (UMLS CUI [1])
cns metastasis
Item
7. multiple cns metastasis or a single cns lesion that does not demonstrate radiographic stability (screening ct of head required only if symptomatic, no radiographic follow-up of single resected lesions required);
boolean
C0686377 (UMLS CUI [1])
blood transfusions
Item
8. blood transfusions within the last 14 days;
boolean
C0005841 (UMLS CUI [1])
previous use of erythropoietin
Item
9. previous use of erythropoietin;
boolean
C0199970 (UMLS CUI [1])
anemia
Item
10. anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);
boolean
C0002871 (UMLS CUI [1])
evidence of untreated folate or vitamin b12 deficiency
Item
11. evidence of untreated folate or vitamin b12 deficiency;
boolean
C0042847 (UMLS CUI [1])
C0016412 (UMLS CUI [2])
uncontrolled hypertension or diastolic blood pressure
Item
12. history of uncontrolled hypertension or diastolic blood pressure greater than 100 mm hg;
boolean
C1868885 (UMLS CUI [1])
C0235222 (UMLS CUI [2])
seizure disorder
Item
13. history of seizure disorder;
boolean
C0014544 (UMLS CUI [1])
hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug
Item
14. known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;
boolean
C0013182 (UMLS CUI [1])
pregnancy, lactation or parturition
Item
15. pregnancy, lactation or parturition within the previous 30 days;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1148523 (UMLS CUI [3])
compliance
Item
16. unwillingness or inability to complete the required qol questionnaires;
boolean
C1321605 (UMLS CUI [1])
condition precluding study compliance
Item
17. mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
geographically inaccessible for treatment or follow-up evaluations
Item
18. geographically inaccessible for treatment or follow-up evaluations;
boolean
C0814423 (UMLS CUI [1])
study participation status
Item
19. currently enrolled in an ongoing therapeutic study;
boolean
C2348568 (UMLS CUI [1])
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