ID

21998

Beschreibung

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

Stichworte

Versionen (1)
  1. 14.05.17 14.05.17 -
Hochgeladen am

14. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00452803

Englisch

Eligibility Lung Cancer NCT00452803

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

nsclc

Datentyp

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.
Beschreibung

nsclc ajcc stage, mediastinal lymph nodes

Datentyp

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.
Beschreibung

tumor amenable to surgical resection

Datentyp

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).
Beschreibung

response evaluation criteria in solid tumors

Datentyp

boolean

Alias
UMLS CUI [1]
C1709926
5. no prior tumor therapy (surgery, 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
6. performance status of 0-1 on ecog scale.
Beschreibung

ecog

Datentyp

boolean

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

age

Datentyp

boolean

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

follow-up compliance

Datentyp

boolean

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

patient condition, radical nsclc surgery

Datentyp

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.
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
11. signed informed consent from patient or legal representative.
Beschreibung

informed consent

Datentyp

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.
Beschreibung

effective contraception, pregnancy test

Datentyp

text

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. 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
5. significant neurological or mental disorder.
Beschreibung

neurological or mental disorder

Datentyp

boolean

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

second primary malignancy

Datentyp

boolean

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

pregnancy, breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Lung Cancer NCT00452803

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