ID

31693

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01403259

Stichworte

Versionen (1)
  1. 21.09.18 21.09.18 -
Rechteinhaber

Fudan University

Hochgeladen am

21. September 2018

DOI

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Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01403259

Englisch

Eligibility Nasopharyngeal Carcinoma NCT01403259

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Incurable, relapsed or metastatic nasopharyngeal carcinoma

Datentyp

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
Beschreibung

Pre-treatment with platinum-containing regimen

Datentyp

boolean

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

ECOG Status

Datentyp

boolean

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

Life expectancy

Datentyp

boolean

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

ANC, Platelet count, Hemoglobin

Datentyp

boolean

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

Bilirubin, ALT and AST

Datentyp

boolean

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

Creatinine, Creatinine clearance

Datentyp

boolean

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

Neuropathy

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
with curable treatment option
Beschreibung

Curative intent

Datentyp

boolean

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

CNS involvement

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Chemotherapy lines

Datentyp

boolean

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

Prior exposure of s-1 or oxaliplatin

Datentyp

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
Beschreibung

History of malignancies

Datentyp

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
Beschreibung

Active infection

Datentyp

boolean

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

Pregnancy status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT01403259

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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