ID

31054

Description

Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine; ODM derived from: https://clinicaltrials.gov/show/NCT00753714

Lien

https://clinicaltrials.gov/show/NCT00753714

Mots-clés

Versions (1)
  1. 15/07/2018 15/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

15 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00753714

Anglais

Eligibility Non Small Cell Lung Cancer NCT00753714

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic confirmation of advanced nsclc (stage iiib with supraclavicular lymph node metastases or pleural effusion or stage iv) on entry into study
Description

Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Secondary malignant neoplasm of lymph node Supraclavicular | Pleural effusion | Non-Small Cell Lung Carcinoma TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C1550301
UMLS CUI [3]
C0032227
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C3258246
one or more measurable lesions at least 10 mm in the longest diameter (ld) by spiral ct scan or 20 mm with conventional techniques according to recist criteria
Description

Measurable lesion Quantity | Longest Diameter Spiral CT scan | Longest Diameter Technique conventional

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0552406
UMLS CUI [2,2]
C0860888
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0449851
UMLS CUI [3,3]
C0439858
chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
Description

Chemotherapy naive | Adjuvant Chemotherapy Previous Completed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0205197
female or male aged 70 years or above
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have received prior anti-cancer therapy except in the adjuvant setting
Description

Cancer treatment Previous | Exception Adjuvant therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677850
inadequate end-organ function or evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial
Description

Organ function Inadequate | Systemic disease Severe | Systemic disease Uncontrolled | Condition Study Subject Participation Status Unfavorable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C3640815
significant cardiovascular event (e.g. myocardial infarction, superior vena cava [svc] syndrome, new york heart association [nyha] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
Description

Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038833
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg
Description

Cardiac Arrhythmia | QTc Bazett formula Measurement Unsuccessful | ECG QTc interval Bazett formula

Type de données

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C0860814
UMLS CUI [2,2]
C4038411
UMLS CUI [2,3]
C0242485
UMLS CUI [2,4]
C1272705
UMLS CUI [3,1]
C2216079
UMLS CUI [3,2]
C4038411
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Similar models

Eligibility Non Small Cell Lung Cancer NCT00753714

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Secondary malignant neoplasm of lymph node Supraclavicular | Pleural effusion | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologic or cytologic confirmation of advanced nsclc (stage iiib with supraclavicular lymph node metastases or pleural effusion or stage iv) on entry into study
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0686619 (UMLS CUI [2,1])
C1550301 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3])
C0007131 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
Measurable lesion Quantity | Longest Diameter Spiral CT scan | Longest Diameter Technique conventional
Item
one or more measurable lesions at least 10 mm in the longest diameter (ld) by spiral ct scan or 20 mm with conventional techniques according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0552406 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0552406 (UMLS CUI [3,1])
C0449851 (UMLS CUI [3,2])
C0439858 (UMLS CUI [3,3])
Chemotherapy naive | Adjuvant Chemotherapy Previous Completed
Item
chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted).
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Age
Item
female or male aged 70 years or above
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Previous | Exception Adjuvant therapy
Item
patients must not have received prior anti-cancer therapy except in the adjuvant setting
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Organ function Inadequate | Systemic disease Severe | Systemic disease Uncontrolled | Condition Study Subject Participation Status Unfavorable
Item
inadequate end-organ function or evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0442893 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0348080 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C3640815 (UMLS CUI [4,3])
Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification
Item
significant cardiovascular event (e.g. myocardial infarction, superior vena cava [svc] syndrome, new york heart association [nyha] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
boolean
C1320716 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038833 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
Cardiac Arrhythmia | QTc Bazett formula Measurement Unsuccessful | ECG QTc interval Bazett formula
Item
history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg
boolean
C0003811 (UMLS CUI [1])
C0860814 (UMLS CUI [2,1])
C4038411 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C1272705 (UMLS CUI [2,4])
C2216079 (UMLS CUI [3,1])
C4038411 (UMLS CUI [3,2])
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