ID

22000

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00452881

Stichworte

Versionen (1)
  1. 14.05.17 14.05.17 -
Hochgeladen am

14. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00452881

Englisch

Eligibility Lung Cancer NCT00452881

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

nsclc

Datentyp

boolean

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

nsclc ajcc stage

Datentyp

boolean

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

complete nsclc tumor resection

Datentyp

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).
Beschreibung

prior tumor therapy

Datentyp

boolean

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

ecog

Datentyp

boolean

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

age

Datentyp

boolean

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

follow-up compliance

Datentyp

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.
Beschreibung

hematologic, hepatic, renal function

Datentyp

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.
Beschreibung

informed consent

Datentyp

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.
Beschreibung

effective contraception, pregnancy test

Datentyp

boolean

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

Exclusion Criteria

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

concurrent tumor therapy

Datentyp

boolean

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

uncontrolled infection

Datentyp

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.
Beschreibung

comorbidities

Datentyp

boolean

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

second primary malignancy

Datentyp

boolean

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

neurological or mental disorder

Datentyp

boolean

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

pregnancy, breast feeding

Datentyp

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
Beschreibung

heart diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
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Ähnliche Modelle

Eligibility Lung Cancer NCT00452881

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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