ID

38504

Beskrivning

TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01282151

Länk

https://clinicaltrials.gov/show/NCT01282151

Nyckelord

Versioner (1)
  1. 2019-10-22 2019-10-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non Small Cell Lung NCT01282151

Engelsk

Eligibility Carcinoma, Non Small Cell Lung NCT01282151

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years old
Beskrivning

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
non-squamous cell type non-small cell lung cancer (nsclc)
Beskrivning

Non-squamous non-small cell lung cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C4324656
stage iv, stage iiib cannot be treated with curative intent or relapsed after surgery or radiation therapy
Beskrivning

TNM clinical staging | Curative treatment Unsuccessful | Recurrent disease Post Operative Surgical Procedures | Recurrent disease Post Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0543467
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1522449
no prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. the last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
Beskrivning

Prior Chemotherapy Absent | Exception Adjuvant Chemotherapy | Exception Concurrent Chemoradiotherapy | Docetaxel Absent | Pemetrexed Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085533
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3178775
UMLS CUI [4,1]
C0246415
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0210657
UMLS CUI [5,2]
C0332197
no prior immunotherapy, biologic therapy
Beskrivning

Prior Immunotherapy Absent | Biological treatment Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514461
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0332197
measurable lesion with response evaluation criteria in solid tumors (recist) version 1.1
Beskrivning

Measurable lesion

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
hemoglobin >=9.0g/dl, platelet >=100,000/ul, neutrophil >=1,500 /ul creatinine <=1.5 x upper normal limit or creatinine clearance >=60 ml/min bilirubin <=1.5 x upper normal limit, transaminases <=2 x upper normal limit alkaline phosphatase <=2 x upper normal limit
Beskrivning

Hemoglobin measurement | Platelet Count measurement | Neutrophil count | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Transaminase Assay | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0919834
UMLS CUI [8]
C0201850
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy, lactating woman
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
woman in child bearing age who refuses to do pregnancy test
Beskrivning

Childbearing Potential Pregnancy Test Refused

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C1705116
moderate or greater than grade 1 motor or sensory neurotoxicity
Beskrivning

Neurotoxicity Motor Moderate | Neurotoxicity Sensory Moderate | Neurotoxicity Motor CTCAE Grades | Neurotoxicity Sensory CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0026609
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C0027883
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C0235032
UMLS CUI [3,2]
C0026609
UMLS CUI [3,3]
C1516728
UMLS CUI [4,1]
C0235032
UMLS CUI [4,2]
C0027883
UMLS CUI [4,3]
C1516728
hypersensitivity to taxane
Beskrivning

Hypersensitivity Taxane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0215136
comorbidity or poor medical conditions
Beskrivning

Comorbidity | Medical condition Poor

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0542537
other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
Beskrivning

Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1880198
concurrent treatment with other investigational drugs within 30 days before randomization
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
active treatment with other anticancer chemotherapy
Beskrivning

Antineoplastic Chemotherapy Regimen Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205394
egfr mutation (exon 19 deletion, l858r, l861q, g719a/c/s)
Beskrivning

EGFR gene mutation | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | EGFR G719A | EGFR G719C | EGFR G719S

Datatyp

boolean

Alias
UMLS CUI [1]
C3266992
UMLS CUI [2]
C3889117
UMLS CUI [3]
C3274204
UMLS CUI [4]
C3274186
UMLS CUI [5]
C3274209
UMLS CUI [6]
C3274211
UMLS CUI [7]
C3274216
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Similar models

Eligibility Carcinoma, Non Small Cell Lung NCT01282151

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Non-squamous non-small cell lung cancer
Item
non-squamous cell type non-small cell lung cancer (nsclc)
boolean
C4324656 (UMLS CUI [1])
TNM clinical staging | Curative treatment Unsuccessful | Recurrent disease Post Operative Surgical Procedures | Recurrent disease Post Therapeutic radiology procedure
Item
stage iv, stage iiib cannot be treated with curative intent or relapsed after surgery or radiation therapy
boolean
C3258246 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Prior Chemotherapy Absent | Exception Adjuvant Chemotherapy | Exception Concurrent Chemoradiotherapy | Docetaxel Absent | Pemetrexed Absent
Item
no prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. the last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3178775 (UMLS CUI [3,2])
C0246415 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0210657 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prior Immunotherapy Absent | Biological treatment Absent
Item
no prior immunotherapy, biologic therapy
boolean
C1514461 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion
Item
measurable lesion with response evaluation criteria in solid tumors (recist) version 1.1
boolean
C1513041 (UMLS CUI [1])
Hemoglobin measurement | Platelet Count measurement | Neutrophil count | Creatinine measurement, serum | Creatinine clearance measurement | Serum total bilirubin measurement | Transaminase Assay | Alkaline phosphatase measurement
Item
hemoglobin >=9.0g/dl, platelet >=100,000/ul, neutrophil >=1,500 /ul creatinine <=1.5 x upper normal limit or creatinine clearance >=60 ml/min bilirubin <=1.5 x upper normal limit, transaminases <=2 x upper normal limit alkaline phosphatase <=2 x upper normal limit
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0919834 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy, lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Pregnancy Test Refused
Item
woman in child bearing age who refuses to do pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Neurotoxicity Motor Moderate | Neurotoxicity Sensory Moderate | Neurotoxicity Motor CTCAE Grades | Neurotoxicity Sensory CTCAE Grades
Item
moderate or greater than grade 1 motor or sensory neurotoxicity
boolean
C0235032 (UMLS CUI [1,1])
C0026609 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0235032 (UMLS CUI [2,1])
C0027883 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0235032 (UMLS CUI [3,1])
C0026609 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
C0235032 (UMLS CUI [4,1])
C0027883 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
Hypersensitivity Taxane
Item
hypersensitivity to taxane
boolean
C0020517 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
Comorbidity | Medical condition Poor
Item
comorbidity or poor medical conditions
boolean
C0009488 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Investigational New Drugs
Item
concurrent treatment with other investigational drugs within 30 days before randomization
boolean
C0013230 (UMLS CUI [1])
Antineoplastic Chemotherapy Regimen Other
Item
active treatment with other anticancer chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
EGFR gene mutation | EGFR exon 19 deletion | EGFR L858R | EGFR L861Q | EGFR G719A | EGFR G719C | EGFR G719S
Item
egfr mutation (exon 19 deletion, l858r, l861q, g719a/c/s)
boolean
C3266992 (UMLS CUI [1])
C3889117 (UMLS CUI [2])
C3274204 (UMLS CUI [3])
C3274186 (UMLS CUI [4])
C3274209 (UMLS CUI [5])
C3274211 (UMLS CUI [6])
C3274216 (UMLS CUI [7])
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