ID

31185

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00887783

Stichworte

Versionen (1)
  1. 25.07.18 25.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Juli 2018

DOI

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Lizenz

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

Englisch

Eligibility Non-small Cell Lung Cancer NCT00887783

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Beschreibung

Age

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

Weight decreased Percentage Timespan

Datentyp

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
Beschreibung

Pulmonary function FEV1

Datentyp

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
Beschreibung

Neutrophil count | Platelet Count measurement

Datentyp

boolean

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

Serum total bilirubin measurement

Datentyp

boolean

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

Alanine aminotransferase measurement

Datentyp

boolean

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

Protocol Compliance

Datentyp

boolean

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

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Lacking Able to swallow Oral medication | Requirement Intravenous Feeding

Datentyp

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
Beschreibung

Peptic Ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
nursing mothers
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT00887783

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