ID

31185

Beskrivning

Navelbine And Radiotherapy in Locally Advanced Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00887783

Länk

https://clinicaltrials.gov/show/NCT00887783

Nyckelord

Versioner (1)
  1. 2018-07-25 2018-07-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00887783

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00887783

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with histologically or cytologically documented diagnosis of locally advanced nsclc stage iib to iiib without pleural effusion
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Pleural effusion Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0032227
UMLS CUI [2,2]
C0332197
performance status 0-1 on the ecog scale
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
weight loss ≤10% during the last 6 months
Beskrivning

Weight decreased Percentage Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
adequate lung function measured as fev1 ≥1.0
Beskrivning

Pulmonary function FEV1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0849974
neutrophile count ≥1.5 x 109/l and platelet count ≥100 x 109/l
Beskrivning

Neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
serum bilirubin ≤1.5 upper limit of normal (uln)
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
alat ≤2 x uln
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
able to comply with study and follow-up procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
patients with reproductive potential must use effective contraception
Beskrivning

Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
written (signed) informed consent to participate in the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
Beskrivning

Systemic disease Unstable | Communicable Disease | Angina, Unstable | Congestive heart failure | Liver disease Severe | Kidney Disease Severe | Metabolic Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0025517
UMLS CUI [7,2]
C0205082
any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
Beskrivning

Prior Chemotherapy Malignant neoplasm of lung | Chemotherapy Neoadjuvant Malignant neoplasm of lung | Adjuvant Chemotherapy Malignant neoplasm of lung

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0242379
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C0242379
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0242379
inability to take oral medication, or requirement of intravenous alimentation
Beskrivning

Lacking Able to swallow Oral medication | Requirement Intravenous Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0021910
active peptic ulcer disease
Beskrivning

Peptic Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
nursing mothers
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00887783

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Pleural effusion Absent
Item
patients with histologically or cytologically documented diagnosis of locally advanced nsclc stage iib to iiib without pleural effusion
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0032227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
ECOG performance status
Item
performance status 0-1 on the ecog scale
boolean
C1520224 (UMLS CUI [1])
Weight decreased Percentage Timespan
Item
weight loss ≤10% during the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Pulmonary function FEV1
Item
adequate lung function measured as fev1 ≥1.0
boolean
C0231921 (UMLS CUI [1,1])
C0849974 (UMLS CUI [1,2])
Neutrophil count | Platelet Count measurement
Item
neutrophile count ≥1.5 x 109/l and platelet count ≥100 x 109/l
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum bilirubin ≤1.5 upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alat ≤2 x uln
boolean
C0201836 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with study and follow-up procedures
boolean
C0525058 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
patients with reproductive potential must use effective contraception
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
written (signed) informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Disease | Angina, Unstable | Congestive heart failure | Liver disease Severe | Kidney Disease Severe | Metabolic Disease Severe
Item
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0025517 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Prior Chemotherapy Malignant neoplasm of lung | Chemotherapy Neoadjuvant Malignant neoplasm of lung | Adjuvant Chemotherapy Malignant neoplasm of lung
Item
prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0242379 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3,1])
C0242379 (UMLS CUI [3,2])
Lacking Able to swallow Oral medication | Requirement Intravenous Feeding
Item
inability to take oral medication, or requirement of intravenous alimentation
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0021910 (UMLS CUI [2,2])
Peptic Ulcer
Item
active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1])
Breast Feeding
Item
nursing mothers
boolean
C0006147 (UMLS CUI [1])
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