ID

31190

Beskrivning

Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00995761

Länk

https://clinicaltrials.gov/show/NCT00995761

Nyckelord

Versioner (1)
  1. 2018-07-26 2018-07-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00995761

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00995761

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who were≥ 65 years of age and they had an easten cooperative oncology group (ecog) performance status (ps) of 0-2, or the patients who were < 65 years of age and they had an ecog ps 2
Beskrivning

Age | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
histologically confirmed non-small cell carcinoma
Beskrivning

Non-small cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1266002
stages iiib-iv disease
Beskrivning

Disease TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dl, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dl), and liver function (total bilirubin ≤1.5 mg/dl and serum transaminase level less than twice the upper limit of normal)
Beskrivning

Parameters Hematologic | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Transaminase Assay

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205488
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0232741
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0919834
at least one bi-dimensionally measurable lesion, according to the response evaluation criteria in solid tumors (recist) version 1.1
Beskrivning

Measurable lesion 2-Dimensional Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
prior chemotherapy, radiotherapy or surgery for their disease,
Beskrivning

Prior Chemotherapy Disease | Prior radiation therapy Disease | Operative Surgical Procedures Previous Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0012634
a history of myocardial infarction in the last 3 months before entry to the study
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
uncontrolled congestive heart failure or hypertension
Beskrivning

Congestive heart failure Uncontrolled | Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
Beskrivning

Diabetic - poor control | Pregnancy | Breast Feeding | Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0751623
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
all the patients provided written informed consent before they entered the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00995761

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | ECOG performance status
Item
patients who were≥ 65 years of age and they had an easten cooperative oncology group (ecog) performance status (ps) of 0-2, or the patients who were < 65 years of age and they had an ecog ps 2
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Non-small cell carcinoma
Item
histologically confirmed non-small cell carcinoma
boolean
C1266002 (UMLS CUI [1])
Disease TNM clinical staging
Item
stages iiib-iv disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Parameters Hematologic | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Transaminase Assay
Item
adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dl, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dl), and liver function (total bilirubin ≤1.5 mg/dl and serum transaminase level less than twice the upper limit of normal)
boolean
C0449381 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0232741 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0919834 (UMLS CUI [9])
Measurable lesion 2-Dimensional Quantity
Item
at least one bi-dimensionally measurable lesion, according to the response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Prior Chemotherapy Disease | Prior radiation therapy Disease | Operative Surgical Procedures Previous Disease
Item
prior chemotherapy, radiotherapy or surgery for their disease,
boolean
C1514457 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
Myocardial Infarction
Item
a history of myocardial infarction in the last 3 months before entry to the study
boolean
C0027051 (UMLS CUI [1])
Congestive heart failure Uncontrolled | Uncontrolled hypertension
Item
uncontrolled congestive heart failure or hypertension
boolean
C0018802 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
Diabetic - poor control | Pregnancy | Breast Feeding | Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma
Item
uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
boolean
C0421258 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0751623 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
Informed Consent
Item
all the patients provided written informed consent before they entered the study
boolean
C0021430 (UMLS CUI [1])
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