ID

31699

Description

Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01417390

Link

https://clinicaltrials.gov/show/NCT01417390

Keywords

  1. 9/21/18 9/21/18 -
  2. 9/21/18 9/21/18 - Sarah Riepenhausen
Copyright Holder

First People's Hospital of Foshan

Uploaded on

September 21, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Nasopharyngeal Carcinoma NCT01417390

Eligibility Nasopharyngeal Carcinoma NCT01417390

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly histologically confirmed non-keratinizing (according to world health organization (who 2005) histologically type).
Description

Non-keratinizing nasopharyngeal carcinome

Data type

boolean

Alias
UMLS CUI [1,1]
C1334926
UMLS CUI [1,2]
C1301142
karnofsky scale (kps) > 70.
Description

Karnofsky Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
tumor staged is according to the 7th american joint commission on cancer edition as stage iii:t1-2n2m0, t3n0-2m0 stage iva:t4n0-2m0 stage ivb:any t、n3.
Description

AJCC Stage

Data type

boolean

Alias
UMLS CUI [1]
C0441915
adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl.
Description

Leucocyte count, hemoglobin, platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) <1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤2.5×uln, and bilirubin ≤uln.
Description

ALT, AST, Alkaline Phosphatase, Bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201913
adequate renal function: creatinine clearance ≥60 ml/min.
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
patients must be informed of the investigational nature of this study and give written informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
who type keratinizing squamous cell carcinoma.
Description

Squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007137
age >60 years or <18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
treatment with palliative intent.
Description

Palliative intent

Data type

boolean

Alias
UMLS CUI [1]
C1285530
pregnancy or lactation.
Description

Pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Description

Prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.
Description

Comorbidity, including heart disease, chronic hepatitis, renal disease, diabetes and emotional disturbance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0022658
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0013985

Similar models

Eligibility Nasopharyngeal Carcinoma NCT01417390

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-keratinizing nasopharyngeal carcinome
Item
patients with newly histologically confirmed non-keratinizing (according to world health organization (who 2005) histologically type).
boolean
C1334926 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Karnofsky Status
Item
karnofsky scale (kps) > 70.
boolean
C0206065 (UMLS CUI [1])
AJCC Stage
Item
tumor staged is according to the 7th american joint commission on cancer edition as stage iii:t1-2n2m0, t3n0-2m0 stage iva:t4n0-2m0 stage ivb:any t、n3.
boolean
C0441915 (UMLS CUI [1])
Leucocyte count, hemoglobin, platelet count
Item
adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
ALT, AST, Alkaline Phosphatase, Bilirubin
Item
normal liver function test: alanine aminotransferase (alt)、aspartate aminotransferase (ast) <1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤2.5×uln, and bilirubin ≤uln.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Creatinine clearance
Item
adequate renal function: creatinine clearance ≥60 ml/min.
boolean
C0373595 (UMLS CUI [1])
Informed consent
Item
patients must be informed of the investigational nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Squamous cell carcinoma
Item
who type keratinizing squamous cell carcinoma.
boolean
C0007137 (UMLS CUI [1])
Age
Item
age >60 years or <18 years.
boolean
C0001779 (UMLS CUI [1])
Palliative intent
Item
treatment with palliative intent.
boolean
C1285530 (UMLS CUI [1])
Pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior treatment
Item
prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
boolean
C1514463 (UMLS CUI [1])
Comorbidity, including heart disease, chronic hepatitis, renal disease, diabetes and emotional disturbance
Item
any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0019189 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0011849 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0013985 (UMLS CUI [6])

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