ID

16672

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00310232

Palabras clave

Versiones (1)
  1. 31/7/16 31/7/16 -
Subido en

31 de julio de 2016

DOI

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Licencia

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

Inglés

Eligibility Non-Small-Cell Lung Carcinoma NCT00310232

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

nsclc stage III or IV

Tipo de datos

boolean

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

hemoglobin

Tipo de datos

boolean

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

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

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;
Descripción

systemic platinum-based chemotherapy

Tipo de datos

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;
Descripción

previous RTx or surgery, no evidenc of disease recurrence

Tipo de datos

boolean

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

planned high dose thoracic radiation therapy

Tipo de datos

boolean

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

clinically active malignancy

Tipo de datos

boolean

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

life expectancy

Tipo de datos

boolean

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

ecog performance status

Tipo de datos

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);
Descripción

cns metastasis

Tipo de datos

boolean

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

blood transfusions

Tipo de datos

boolean

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

previous use of erythropoietin

Tipo de datos

boolean

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

anemia

Tipo de datos

boolean

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

evidence of untreated folate or vitamin b12 deficiency

Tipo de datos

boolean

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

uncontrolled hypertension or diastolic blood pressure

Tipo de datos

boolean

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

seizure disorder

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

pregnancy, lactation or parturition

Tipo de datos

boolean

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

compliance

Tipo de datos

boolean

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

condition precluding study compliance

Tipo de datos

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;
Descripción

geographically inaccessible for treatment or follow-up evaluations

Tipo de datos

boolean

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

study participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Non-Small-Cell Lung Carcinoma NCT00310232

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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