ID

41145

Descrição

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Phase II Randomized Control Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02143388

Link

https://clinicaltrials.gov/show/NCT02143388

Palavras-chave

  1. 30/06/2020 30/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly histologic diagnosis of nasopharyngeal carcinoma(who ii/iii)
Descrição

Nasopharyngeal carcinoma WHO tumor classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C1301142
clinical stage iii~ivb(uicc 7th)
Descrição

TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3258246
meet at least one factor below :1 primary tumor suvmax>10 in 18f-fdg pet/ct;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 t4n2m0; 5 t1-4n3m0;6 ebv-dna>2×10e4 copy/l
Descrição

Primary Neoplasm | SUV Maximum FDG-PET/CT | Tumor Volume | Cervical lymph nodes metastatic multiple | Cervical lymph node Diameter | TNM clinical staging | Epstein-Barr virus DNA Measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C2348529
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C4521453
UMLS CUI [3]
C0475276
UMLS CUI [4,1]
C0588054
UMLS CUI [4,2]
C1522484
UMLS CUI [4,3]
C0439064
UMLS CUI [5,1]
C0588054
UMLS CUI [5,2]
C1301886
UMLS CUI [6]
C3258246
UMLS CUI [7,1]
C0369169
UMLS CUI [7,2]
C0242485
range from 18~70 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
wbc count ≥ 4×109/l,hemoglobin ≥ 100g/l, platelet count ≥ 100×109/l
Descrição

White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
alt or ast < 2.5×uln、bilirubin < 1.5×uln
Descrição

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C1278039
oserum creatinine < 1.5×uln
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system metastases
Descrição

CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
suitable for local treatment
Descrição

Patients suitable Local Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1517925
uncontrolled seizure disorder or other serious neurologic disease
Descrição

Seizure Uncontrolled | Nervous system disorder Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205404
clinically significant cardiac or respiratory disease
Descrição

Heart Disease | Respiration Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0035204
drug or alcohol addition
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
do not have full capacity for civil acts
Descrição

Legal capacity Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0439801
severe complication, active infection
Descrição

Severe medical complication | Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2]
C0009450
concurrent immunotherapy or hormone therapy for other diseases
Descrição

Immunotherapy Disease Other | Hormone Therapy Disease Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0205394
pregnancy or lactation
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Similar models

Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma WHO tumor classification
Item
newly histologic diagnosis of nasopharyngeal carcinoma(who ii/iii)
boolean
C2931822 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
TNM clinical staging
Item
clinical stage iii~ivb(uicc 7th)
boolean
C3258246 (UMLS CUI [1])
Primary Neoplasm | SUV Maximum FDG-PET/CT | Tumor Volume | Cervical lymph nodes metastatic multiple | Cervical lymph node Diameter | TNM clinical staging | Epstein-Barr virus DNA Measurement
Item
meet at least one factor below :1 primary tumor suvmax>10 in 18f-fdg pet/ct;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 t4n2m0; 5 t1-4n3m0;6 ebv-dna>2×10e4 copy/l
boolean
C0677930 (UMLS CUI [1])
C2348529 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C4521453 (UMLS CUI [2,3])
C0475276 (UMLS CUI [3])
C0588054 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
C0439064 (UMLS CUI [4,3])
C0588054 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C3258246 (UMLS CUI [6])
C0369169 (UMLS CUI [7,1])
C0242485 (UMLS CUI [7,2])
Age
Item
range from 18~70 years old
boolean
C0001779 (UMLS CUI [1])
White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
wbc count ≥ 4×109/l,hemoglobin ≥ 100g/l, platelet count ≥ 100×109/l
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
alt or ast < 2.5×uln、bilirubin < 1.5×uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Creatinine measurement, serum
Item
oserum creatinine < 1.5×uln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Patients suitable Local Therapy
Item
suitable for local treatment
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1517925 (UMLS CUI [1,3])
Seizure Uncontrolled | Nervous system disorder Serious
Item
uncontrolled seizure disorder or other serious neurologic disease
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Heart Disease | Respiration Disorder
Item
clinically significant cardiac or respiratory disease
boolean
C0018799 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
Substance Dependence
Item
drug or alcohol addition
boolean
C0038580 (UMLS CUI [1])
Legal capacity Limited
Item
do not have full capacity for civil acts
boolean
C0683673 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Severe medical complication | Communicable Disease
Item
severe complication, active infection
boolean
C3495031 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Immunotherapy Disease Other | Hormone Therapy Disease Other
Item
concurrent immunotherapy or hormone therapy for other diseases
boolean
C0021083 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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