ID

41145

Description

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

Keywords

Versions (1)
  1. 6/30/20 6/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

English

Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Nasopharyngeal carcinoma WHO tumor classification

Data type

boolean

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

TNM clinical staging

Data type

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
Description

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

Data type

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
Description

Age

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
central nervous system metastases
Description

CNS metastases

Data type

boolean

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

Patients suitable Local Therapy

Data type

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
Description

Seizure Uncontrolled | Nervous system disorder Serious

Data type

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
Description

Heart Disease | Respiration Disorder

Data type

boolean

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

Substance Dependence

Data type

boolean

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

Legal capacity Limited

Data type

boolean

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

Severe medical complication | Communicable Disease

Data type

boolean

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

Immunotherapy Disease Other | Hormone Therapy Disease Other

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Local Advanced High Risk Nasopharyngeal Carcinoma NCT02143388

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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