ID

21998

Descrição

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00452803

Link

https://clinicaltrials.gov/show/NCT00452803

Palavras-chave

Versões (1)
  1. 14/05/2017 14/05/2017 -
Transferido a

14 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00452803

Inglês

Eligibility Lung Cancer NCT00452803

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic or cytologic diagnosis of non-small cell lung cancer.
Descrição

nsclc

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
2. presence of biopsy-proven n2 stage iiia, according to the american joint committee on cancer (ajcc), with none of the mediastinal lymph nodes > 3 cm in largest diameter.
Descrição

nsclc ajcc stage, mediastinal lymph nodes

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C0441915
UMLS CUI [1,4]
C0449393
3. tumor amenable to surgical resection.
Descrição

tumor amenable to surgical resection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0728940
4. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).
Descrição

response evaluation criteria in solid tumors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1709926
5. no prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
Descrição

prior tumor therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1514463
6. performance status of 0-1 on ecog scale.
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
7. at least 18 years old.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
8. patient compliance that allows adequate follow-up.
Descrição

follow-up compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
9. medical fitness of patients adequate for radical nsclc surgery.
Descrição

patient condition, radical nsclc surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0439807
10. adequate organ function including the following:adequate hematologic function: wbc count ≥ 4,000/ul, absolute neutrophil count (anc) ≥ 1,500/ul, platelet count ≥ 100,000/ul, and hemoglobin ≥ 10 gm/dl.adequate hepatic function: bilirubin ≤ 1.5 x unl, alt or ast ≤ 2.5 x unl.adequate renal function: creatinine ≤ 1.5mg/dl.
Descrição

hematologic, hepatic, renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0948762
UMLS CUI [1,3]
C0005821
UMLS CUI [1,4]
C0019046
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1278039
UMLS CUI [2,3]
C0201899
UMLS CUI [2,4]
C0201836
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0201976
11. signed informed consent from patient or legal representative.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
12. patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. females with childbearing potential must have a negative urine hcg test within 7 days prior to study enrollment.
Descrição

effective contraception, pregnancy test

Tipo de dados

text

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032976
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
Descrição

concurrent tumor therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0920425
2. active uncontrolled infection.
Descrição

uncontrolled infection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
3. serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
Descrição

comorbidities

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
4. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
Descrição

heart diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
5. significant neurological or mental disorder.
Descrição

neurological or mental disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
6. second primary malignancy.
Descrição

second primary malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751623
7. pregnant or nursing.
Descrição

pregnancy, breast feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lung Cancer NCT00452803

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
nsclc
Item
1. histologic or cytologic diagnosis of non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
nsclc ajcc stage, mediastinal lymph nodes
Item
2. presence of biopsy-proven n2 stage iiia, according to the american joint committee on cancer (ajcc), with none of the mediastinal lymph nodes > 3 cm in largest diameter.
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0441915 (UMLS CUI [1,3])
C0449393 (UMLS CUI [1,4])
tumor amenable to surgical resection
Item
3. tumor amenable to surgical resection.
boolean
C0006826 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
response evaluation criteria in solid tumors
Item
4. at least one unidimensional measurable lesion meeting response evaluation criteria in solid tumors (recist. 2000).
boolean
C1709926 (UMLS CUI [1])
prior tumor therapy
Item
5. no prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
boolean
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
ecog
Item
6. performance status of 0-1 on ecog scale.
boolean
C1520224 (UMLS CUI [1])
age
Item
7. at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
follow-up compliance
Item
8. patient compliance that allows adequate follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
patient condition, radical nsclc surgery
Item
9. medical fitness of patients adequate for radical nsclc surgery.
boolean
C0683521 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0439807 (UMLS CUI [1,4])
hematologic, hepatic, renal function
Item
10. adequate organ function including the following:adequate hematologic function: wbc count ≥ 4,000/ul, absolute neutrophil count (anc) ≥ 1,500/ul, platelet count ≥ 100,000/ul, and hemoglobin ≥ 10 gm/dl.adequate hepatic function: bilirubin ≤ 1.5 x unl, alt or ast ≤ 2.5 x unl.adequate renal function: creatinine ≤ 1.5mg/dl.
boolean
C0221130 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,3])
C0019046 (UMLS CUI [1,4])
C0232741 (UMLS CUI [2,1])
C1278039 (UMLS CUI [2,2])
C0201899 (UMLS CUI [2,3])
C0201836 (UMLS CUI [2,4])
C0232804 (UMLS CUI [3,1])
C0201976 (UMLS CUI [3,2])
informed consent
Item
11. signed informed consent from patient or legal representative.
boolean
C0021430 (UMLS CUI [1])
effective contraception, pregnancy test
Item
12. patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. females with childbearing potential must have a negative urine hcg test within 7 days prior to study enrollment.
text
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
concurrent tumor therapy
Item
1. concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
boolean
C0009429 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
uncontrolled infection
Item
2. active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
comorbidities
Item
3. serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
boolean
C0009488 (UMLS CUI [1])
heart diseases
Item
4. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
boolean
C0018799 (UMLS CUI [1])
neurological or mental disorder
Item
5. significant neurological or mental disorder.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
second primary malignancy
Item
6. second primary malignancy.
boolean
C0751623 (UMLS CUI [1])
pregnancy, breast feeding
Item
7. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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