ID

32604

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00653939

Trefwoorden

Versies (1)
  1. 08-11-18 08-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 november 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Tumors NCT00653939

Engels

Eligibility Tumors NCT00653939

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Tumors NCT00653939
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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)
Beschrijving

Measurable Disease CT scan

Datatype

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) .
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate blood counts
Beschrijving

Blood Count

Datatype

boolean

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

Liver function | Renal function

Datatype

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.
Beschrijving

Informed Consent | Informed Consent Patient Representatives

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
predominant squamous cell nsclc histology.
Beschrijving

Squamous non-small cell lung cancer predominant

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Blood Coagulation Disorders

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Uncontrolled hypertension | Pharmaceutical Preparations Resistant

Datatype

boolean

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

Communicable Disease Uncontrolled

Datatype

boolean

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

HIV Infection

Datatype

boolean

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

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

Datatype

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.
Beschrijving

Eligibility Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
Terug naar het begin van de pagina

Similar models

Eligibility Tumors NCT00653939

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Tumors NCT00653939
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial