ID

41196

Beskrivning

Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01266512

Länk

https://clinicaltrials.gov/show/NCT01266512

Nyckelord

Versioner (1)
  1. 2020-07-11 2020-07-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juli 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lung Neoplasms NCT01266512

Engelsk

Eligibility Lung Neoplasms NCT01266512

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically proven locally advanced, inoperable, confirmed by pet scan (thorax/
Beskrivning

Locally Advanced Inoperable | PET scan chest | PET scan Upper abdomen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205179
UMLS CUI [1,2]
C1517927
UMLS CUI [1,3]
C0205187
UMLS CUI [2]
C2073388
UMLS CUI [3,1]
C0032743
UMLS CUI [3,2]
C2937240
upper abdomen) to be international stage iii (2009) nsclc and without multifocal tumours in the lung
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Lung Neoplasms Multifocal Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0024121
UMLS CUI [2,2]
C0205292
UMLS CUI [2,3]
C0332197
disease volume encompassible within a tolerable planning target volume treated to 66 gy
Beskrivning

Disease Volume | Planning target volume Tolerable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449468
UMLS CUI [2,1]
C0454199
UMLS CUI [2,2]
C4053931
fev1 (force expiratory volume in 1 second) >1000 ml
Beskrivning

FEV1

Datatyp

boolean

Alias
UMLS CUI [1]
C0849974
hemoglobin ≥ 9.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count (anc) ≥ 1,500/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin ≥ 1.5 times the upper limit of normal
Beskrivning

SERUM TOTAL BILIRUBIN ELEVATED

Datatyp

boolean

Alias
UMLS CUI [1]
C0595866
alt (alanine aminotransferase) and ast (aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Deranged liver function tests

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0857338
ecog (eastern cooperative oncology group) ps 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
Beskrivning

Radiotherapy to thorax | Chemotherapy | Molecular Targeted Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C0392920
UMLS CUI [3]
C2699893
inadequate lung function (exercise tolerance less than 1 fos/fight of stairs, fev1 < 1 l/sec, or raised pco2)
Beskrivning

Lung function testing abnormal | Exercise tolerance test abnormal | FEV1 | PCO2 increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0476405
UMLS CUI [2]
C0149612
UMLS CUI [3]
C0849974
UMLS CUI [4]
C0858343
history of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
Beskrivning

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Premedication | Medical contraindication Premedication | Hypersensitivity Polysorbate 80 products | Medical contraindication Polysorbate 80 products

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0033045
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0033045
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0032601
UMLS CUI [5,3]
C1254351
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0032601
UMLS CUI [6,3]
C1254351
pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Serum pregnancy test Unwilling | Childbearing Potential Serum pregnancy test Unable | Childbearing Potential Urine pregnancy test Unwilling | Childbearing Potential Urine pregnancy test Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430064
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430064
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430056
UMLS CUI [6,3]
C0558080
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430056
UMLS CUI [7,3]
C1299582
participation in a clinical trial with any investigational drug used and within 30 days prior to study entry
Beskrivning

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status | Considerations Incomplete

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0205257
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Similar models

Eligibility Lung Neoplasms NCT01266512

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally Advanced Inoperable | PET scan chest | PET scan Upper abdomen
Item
pathologically proven locally advanced, inoperable, confirmed by pet scan (thorax/
boolean
C0205179 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
C2073388 (UMLS CUI [2])
C0032743 (UMLS CUI [3,1])
C2937240 (UMLS CUI [3,2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Lung Neoplasms Multifocal Absent
Item
upper abdomen) to be international stage iii (2009) nsclc and without multifocal tumours in the lung
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0024121 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Disease Volume | Planning target volume Tolerable
Item
disease volume encompassible within a tolerable planning target volume treated to 66 gy
boolean
C0012634 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0454199 (UMLS CUI [2,1])
C4053931 (UMLS CUI [2,2])
FEV1
Item
fev1 (force expiratory volume in 1 second) >1000 ml
boolean
C0849974 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
total bilirubin ≥ 1.5 times the upper limit of normal
boolean
C0595866 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Deranged liver function tests
Item
alt (alanine aminotransferase) and ast (aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0857338 (UMLS CUI [3])
ECOG performance status
Item
ecog (eastern cooperative oncology group) ps 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to thorax | Chemotherapy | Molecular Targeted Therapy
Item
previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
boolean
C4038705 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C2699893 (UMLS CUI [3])
Lung function testing abnormal | Exercise tolerance test abnormal | FEV1 | PCO2 increased
Item
inadequate lung function (exercise tolerance less than 1 fos/fight of stairs, fev1 < 1 l/sec, or raised pco2)
boolean
C0476405 (UMLS CUI [1])
C0149612 (UMLS CUI [2])
C0849974 (UMLS CUI [3])
C0858343 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Premedication | Medical contraindication Premedication | Hypersensitivity Polysorbate 80 products | Medical contraindication Polysorbate 80 products
Item
history of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0033045 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0033045 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0032601 (UMLS CUI [5,2])
C1254351 (UMLS CUI [5,3])
C1301624 (UMLS CUI [6,1])
C0032601 (UMLS CUI [6,2])
C1254351 (UMLS CUI [6,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Serum pregnancy test Unwilling | Childbearing Potential Serum pregnancy test Unable | Childbearing Potential Urine pregnancy test Unwilling | Childbearing Potential Urine pregnancy test Unable
Item
pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430064 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0430064 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0430056 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C3831118 (UMLS CUI [7,1])
C0430056 (UMLS CUI [7,2])
C1299582 (UMLS CUI [7,3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
participation in a clinical trial with any investigational drug used and within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Study Subject Participation Status | Considerations Incomplete
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
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