ID

32604

Beskrivning

A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00653939

Länk

https://clinicaltrials.gov/show/NCT00653939

Nyckelord

Versioner (1)
  1. 2018-11-08 2018-11-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Tumors NCT00653939

Engelsk

Eligibility Tumors NCT00653939

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Tumors NCT00653939
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed stage iiib nsclc with malignant pleural effusion, or stage iv disease
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant | Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0080032
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C3258246
measurable disease on ct scan (by the response evaluation criteria in solid tumors [recist] criteria)
Beskrivning

Measurable Disease CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 (which means able to independently care for self and to perform light work) .
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate blood counts
Beskrivning

Blood Count

Datatyp

boolean

Alias
UMLS CUI [1]
C0005771
adequate liver and kidney function
Beskrivning

Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
predominant squamous cell nsclc histology.
Beskrivning

Squamous non-small cell lung cancer predominant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4509816
UMLS CUI [1,2]
C1542147
history of treatment for nsclc with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
Beskrivning

Chemotherapy NSCLC | Biological treatment NSCLC | Immunotherapy NSCLC | Operative Surgical Procedures Acceptable | Therapeutic radiology procedure Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0007131
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C1879533
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C1879533
brain (cns) metastasis by head ct scan or mri
Beskrivning

Metastatic malignant neoplasm to brain CT scan of head | Metastatic malignant neoplasm to brain MRI of head

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0202691
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0412674
subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (psa) of < 4.0 mg/dl. subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the medical monitor.
Beskrivning

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Cervical Intraepithelial Neoplasia | Exception Prostate carcinoma Localized PSA measurement | Exception Curative treatment Cancer Other | Exception Neoplasm Metastasis Absent | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0206708
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C0392752
UMLS CUI [4,4]
C0201544
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0027627
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
history of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
Beskrivning

Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
certain cardiac disorders such as recent myocardial infarction (mi), severe congestive heart failure, certain types of abnormal cardiac rhythm
Beskrivning

Heart Diseases | Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0003811
uncontrolled high blood pressure despite medications
Beskrivning

Uncontrolled hypertension | Pharmaceutical Preparations Resistant

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332325
uncontrolled, clinically significant active infection.
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
known hiv
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
known hypersensitivity to any of the components of ca4p, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes.
Beskrivning

Hypersensitivity CA4P | Paclitaxel allergy | Carboplatin allergy | Hypersensitivity Bevacizumab | Contrast dye allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0962508
UMLS CUI [2]
C0570707
UMLS CUI [3]
C0570701
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0796392
UMLS CUI [5]
C0742797
details of the above and additional inclusion and exclusion criteria can be discussed with an investigator.
Beskrivning

Eligibility Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Tumors NCT00653939

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Tumors NCT00653939
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural Effusion, Malignant | Disease TNM clinical staging
Item
pathologically confirmed stage iiib nsclc with malignant pleural effusion, or stage iv disease
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0080032 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Measurable Disease CT scan
Item
measurable disease on ct scan (by the response evaluation criteria in solid tumors [recist] criteria)
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 (which means able to independently care for self and to perform light work) .
boolean
C1520224 (UMLS CUI [1])
Blood Count
Item
adequate blood counts
boolean
C0005771 (UMLS CUI [1])
Liver function | Renal function
Item
adequate liver and kidney function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representatives
Item
subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Squamous non-small cell lung cancer predominant
Item
predominant squamous cell nsclc histology.
boolean
C4509816 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chemotherapy NSCLC | Biological treatment NSCLC | Immunotherapy NSCLC | Operative Surgical Procedures Acceptable | Therapeutic radiology procedure Acceptable
Item
history of treatment for nsclc with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C1879533 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C1879533 (UMLS CUI [5,2])
Metastatic malignant neoplasm to brain CT scan of head | Metastatic malignant neoplasm to brain MRI of head
Item
brain (cns) metastasis by head ct scan or mri
boolean
C0220650 (UMLS CUI [1,1])
C0202691 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0412674 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Cervical Intraepithelial Neoplasia | Exception Prostate carcinoma Localized PSA measurement | Exception Curative treatment Cancer Other | Exception Neoplasm Metastasis Absent | Exception Disease Free of
Item
subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (psa) of < 4.0 mg/dl. subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the medical monitor.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0392752 (UMLS CUI [4,3])
C0201544 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0027627 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
Blood Coagulation Disorders
Item
history of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
boolean
C0005779 (UMLS CUI [1])
Heart Diseases | Myocardial Infarction | Congestive heart failure Severe | Cardiac Arrhythmia
Item
certain cardiac disorders such as recent myocardial infarction (mi), severe congestive heart failure, certain types of abnormal cardiac rhythm
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
Uncontrolled hypertension | Pharmaceutical Preparations Resistant
Item
uncontrolled high blood pressure despite medications
boolean
C1868885 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
uncontrolled, clinically significant active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
HIV Infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])
Hypersensitivity CA4P | Paclitaxel allergy | Carboplatin allergy | Hypersensitivity Bevacizumab | Contrast dye allergy
Item
known hypersensitivity to any of the components of ca4p, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes.
boolean
C0020517 (UMLS CUI [1,1])
C0962508 (UMLS CUI [1,2])
C0570707 (UMLS CUI [2])
C0570701 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0796392 (UMLS CUI [4,2])
C0742797 (UMLS CUI [5])
Eligibility Criteria Additional
Item
details of the above and additional inclusion and exclusion criteria can be discussed with an investigator.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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