ID

31693

Beschrijving

SOX as Salvage Treatment in Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01403259

Link

https://clinicaltrials.gov/show/NCT01403259

Trefwoorden

Versies (1)
  1. 21-09-18 21-09-18 -
Houder van rechten

Fudan University

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21 september 2018

DOI

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Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01403259

Engels

Eligibility Nasopharyngeal Carcinoma NCT01403259

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age range: 18-75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
Beschrijving

Incurable, relapsed or metastatic nasopharyngeal carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0175969
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0277556
UMLS CUI [3,1]
C2931822
UMLS CUI [3,2]
C0027627
prior exposure of at least one line of platinum-containing regimen
Beschrijving

Pre-treatment with platinum-containing regimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3536920
ecog performance status 0-1
Beschrijving

ECOG Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of more than 3 months
Beschrijving

Life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
bone marrow function: anc≧1.5×10^9/l, plt≧100×10^9/l, hb≧80g/l
Beschrijving

ANC, Platelet count, Hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
liver function: total bilirubin, alt and ast <1.5×unl
Beschrijving

Bilirubin, ALT and AST

Datatype

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
renal function: cr<1.5×unl, ccr≧50ml/min
Beschrijving

Creatinine, Creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
without > 1 grade of neuropathy
Beschrijving

Neuropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1298908
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
with curable treatment option
Beschrijving

Curative intent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1276305
UMLS CUI [1,2]
C0332149
with cns involvement
Beschrijving

CNS involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0449389
prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
Beschrijving

Prior platinum exposure in radiochemotherapy or as neo-/adjuvant regimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C3536920
UMLS CUI [1,3]
C0600558
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C3536920
UMLS CUI [2,3]
C1522673
UMLS CUI [3,1]
C0521116
UMLS CUI [3,2]
C1522449
treated with > 2 lines of palliative chemotherapy
Beschrijving

Chemotherapy lines

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1285530
with prior exposure of s-1 or oxaliplatin
Beschrijving

Prior exposure of s-1 or oxaliplatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0069717
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0879262
history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Beschrijving

History of malignancies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0851140
significant active infection
Beschrijving

Active infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
pregnant or lactating women
Beschrijving

Pregnancy status

Datatype

boolean

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

Eligibility Nasopharyngeal Carcinoma NCT01403259

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age range: 18-75 years old
boolean
C0001779 (UMLS CUI [1])
Incurable, relapsed or metastatic nasopharyngeal carcinoma
Item
histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
boolean
C2931822 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C2931822 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C2931822 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Pre-treatment with platinum-containing regimen
Item
prior exposure of at least one line of platinum-containing regimen
boolean
C1514463 (UMLS CUI [1,1])
C3536920 (UMLS CUI [1,2])
ECOG Status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
ANC, Platelet count, Hemoglobin
Item
bone marrow function: anc≧1.5×10^9/l, plt≧100×10^9/l, hb≧80g/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Bilirubin, ALT and AST
Item
liver function: total bilirubin, alt and ast <1.5×unl
boolean
C0201913 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Creatinine, Creatinine clearance
Item
renal function: cr<1.5×unl, ccr≧50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Neuropathy
Item
without > 1 grade of neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Curative intent
Item
with curable treatment option
boolean
C1276305 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
CNS involvement
Item
with cns involvement
boolean
C0449389 (UMLS CUI [1])
Prior platinum exposure in radiochemotherapy or as neo-/adjuvant regimen
Item
prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
boolean
C1514457 (UMLS CUI [1,1])
C3536920 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C3536920 (UMLS CUI [2,2])
C1522673 (UMLS CUI [2,3])
C0521116 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
Chemotherapy lines
Item
treated with > 2 lines of palliative chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
Prior exposure of s-1 or oxaliplatin
Item
with prior exposure of s-1 or oxaliplatin
boolean
C1514457 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0879262 (UMLS CUI [2,2])
History of malignancies
Item
history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Active infection
Item
significant active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Pregnancy status
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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