ID

22000

Descrizione

Adjuvant Gemcitabine Plus Oxaliplatin Versus Gemcitabine Plus Cisplatin for Completely Resected Stage IB/II/IIIA NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00452881

collegamento

https://clinicaltrials.gov/show/NCT00452881

Keywords

versioni (1)
  1. 14/05/17 14/05/17 -
Caricato su

14 maggio 2017

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00452881

Inglese

Eligibility Lung Cancer NCT00452881

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic diagnosis of non-small cell lung cancer.
Descrizione

nsclc

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007131
2. presence of pathological stage ib, ii or iiia, according to the american joint committee on cancer (ajcc).
Descrizione

nsclc ajcc stage

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
UMLS CUI [1,3]
C0441915
3. completely resected tumor at ncc hospital.
Descrizione

complete nsclc tumor resection

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0015250
4. no prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
Descrizione

prior tumor therapy

Tipo di dati

boolean

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

ecog

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
6. at least 18 years old
Descrizione

age

Tipo di dati

boolean

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

follow-up compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
8. 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 ³ 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.
Descrizione

hematologic, hepatic, renal function

Tipo di dati

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
9. signed informed consent from patient or legal representative.
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
10. 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.
Descrizione

effective contraception, pregnancy test

Tipo di dati

boolean

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

Exclusion Criteria

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

concurrent tumor therapy

Tipo di dati

boolean

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

uncontrolled infection

Tipo di dati

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.
Descrizione

comorbidities

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
4. second primary malignancy.
Descrizione

second primary malignancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0751623
5. significant neurological or mental disorder.
Descrizione

neurological or mental disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
6. pregnant or nursing.
Descrizione

pregnancy, breast feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
Descrizione

heart diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018799
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Similar models

Eligibility Lung Cancer NCT00452881

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
nsclc
Item
1. histologic diagnosis of non-small cell lung cancer.
boolean
C0007131 (UMLS CUI [1])
nsclc ajcc stage
Item
2. presence of pathological stage ib, ii or iiia, according to the american joint committee on cancer (ajcc).
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0441915 (UMLS CUI [1,3])
complete nsclc tumor resection
Item
3. completely resected tumor at ncc hospital.
boolean
C0007131 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
prior tumor therapy
Item
4. no prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
boolean
C0920425 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
ecog
Item
5. performance status of 0-1 on ecog scale.
boolean
C1520224 (UMLS CUI [1])
age
Item
6. at least 18 years old
boolean
C0001779 (UMLS CUI [1])
follow-up compliance
Item
7. patient compliance that allows adequate follow-up.
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
hematologic, hepatic, renal function
Item
8. 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 ³ 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
9. signed informed consent from patient or legal representative.
boolean
C0021430 (UMLS CUI [1])
effective contraception, pregnancy test
Item
10. 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.
boolean
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])
second primary malignancy
Item
4. second primary malignancy.
boolean
C0751623 (UMLS CUI [1])
neurological or mental disorder
Item
5. significant neurological or mental disorder.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
pregnancy, breast feeding
Item
6. pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
heart diseases
Item
7. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
boolean
C0018799 (UMLS CUI [1])
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