ID

31059

Beskrivning

A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01023347

Länk

https://clinicaltrials.gov/show/NCT01023347

Nyckelord

Versioner (1)
  1. 2018-07-16 2018-07-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT01023347

Engelsk

Eligibility Non Small Cell Lung Cancer NCT01023347

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological evidence of locally advanced, metastatic or recurrent nsclc (stage iiib or iv)
Beskrivning

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent TNM clinical staging

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]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0278517
UMLS CUI [3,2]
C3258246
at least one measurable lesion(s) by recist criteria
Beskrivning

Measurable Disease Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
no previous palliative chemotherapy
Beskrivning

Prior Chemotherapy Palliative Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1285530
UMLS CUI [1,3]
C0332197
age 18 or higher.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog ps 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 3 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic, hepatic, renal function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul)
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
adequate liver function (≤ total bilirubin ≤ 1.5 upper normal limit, ≤ ast/alt x 2.5 upper normal limit, alkaline phosphatase ≤ 2.5 upper normal limit)
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
adequate renal function (≤ serum creatinine 1.5 mg/dl)
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior chemotherapy for nsclc
Beskrivning

Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
patients with malignancies (other than nsclc), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
Beskrivning

Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
peripheral neuropathy ≥ grade 2 (nci ctc, version 3.0)
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
clinically significant cardiac disease (medically uncontrollable heart disease)
Beskrivning

Heart Disease Control Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C1272705
active infection or other serious medical illness
Beskrivning

Communicable Disease | Illness Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
contraindication to any drug contained in the chemotherapy regimen
Beskrivning

Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0392920
pregnant or lactating women were excluded.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non Small Cell Lung Cancer NCT01023347

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Non-small cell lung cancer recurrent TNM clinical staging
Item
histological or cytological evidence of locally advanced, metastatic or recurrent nsclc (stage iiib or iv)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278517 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
Measurable Disease Quantity
Item
at least one measurable lesion(s) by recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prior Chemotherapy Palliative Absent
Item
no previous palliative chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
age 18 or higher.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog ps 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic, renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate liver function (≤ total bilirubin ≤ 1.5 upper normal limit, ≤ ast/alt x 2.5 upper normal limit, alkaline phosphatase ≤ 2.5 upper normal limit)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
adequate renal function (≤ serum creatinine 1.5 mg/dl)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
no prior chemotherapy for nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Non-Small Cell Lung Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
patients with malignancies (other than nsclc), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy ≥ grade 2 (nci ctc, version 3.0)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Heart Disease Control Unsuccessful
Item
clinically significant cardiac disease (medically uncontrollable heart disease)
boolean
C0018799 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Communicable Disease | Illness Serious
Item
active infection or other serious medical illness
boolean
C0009450 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Medical contraindication Pharmaceutical Preparations Chemotherapy Regimen
Item
contraindication to any drug contained in the chemotherapy regimen
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women were excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tillbaka till toppen 

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