ID

31689

Descripción

Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01271439 Collaborating Parties: Zhejiang Cancer Hospital Wenzhou Medical University The First Affiliate Hospital of Guangxi Medical College Xijing Hospital Hunan Cancer Hospital Jiangxi Provincial Cancer Hospital Wuhan Union Hospital, China Wuhan University Hubei Cancer Hospital Tongji University Cancer Hospital of Shantou University Shenzhen People's Hospital First People's Hospital of Foshan

Link

https://clinicaltrials.gov/show/NCT01271439

Palabras clave

Versiones (2)
  1. 16/9/18 16/9/18 -
  2. 21/9/18 21/9/18 -
Titular de derechos de autor

Sun Yat-sen University

Subido en

21 de septiembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01271439

Inglés

Eligibility Nasopharyngeal Carcinoma NCT01271439

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of nasopharyngeal carcinoma
Descripción

Histological Diagnosis of nasopharyngeal carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0679557
range from 18～69 years old
Descripción

Age group

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
t3-4，n0-2，m0 (ajcc 2009)
Descripción

TNM Stage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0441915
kps ≥ 80
Descripción

KPS Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
nonmetastatic diseases
Descripción

Nonmetastatic diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0445092
wbc count ≥ 4×10^9/l，hemoglobin ≥ 100g/l， platelet count ≥ 100×10^9/l
Descripción

WBC, hemoglobin and platelet count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
alt or ast ＜ 1.5×uln, bilirubin ＜ 1.5×uln
Descripción

Alt, ast and bilirubin

Tipo de datos

boolean

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

Creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
distan metastases
Descripción

Distant metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1302548
previously treated (surgery，chemotherapy, radiation therapy，egfr targeted therapy or immunotherapy)
Descripción

Cancer previously treated with chemotherapy, surgery, immunotherapy, radiotherapy and/or egfr targeted therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0543467
UMLS CUI [2]
C1514457
UMLS CUI [3]
C1514461
UMLS CUI [4,1]
C2114510
UMLS CUI [4,2]
C1522449
UMLS CUI [5,1]
C2114510
UMLS CUI [5,2]
C1739039
UMLS CUI [5,3]
C2985566
second malignancy within 5 years
Descripción

Previous malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
previous therapy with an investigational agent
Descripción

Previous therapy with investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C1521826
uncontrolled seizure disorder or other serious neurologic disease
Descripción

Uncontrolled seizure or serious neurologic disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205082
≥ grade ш allergic reaction to any drug including in this study
Descripción

Allergy to drugs in the study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0205082
clinically significant cardiac or respiratory disease
Descripción

Cardiac or respiratory comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
creatinine clearance < 30ml/min
Descripción

Creatinine clearance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
drug or alcohol addition
Descripción

Substance abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
do not have full capacity for civil acts
Descripción

Capacity for civil acts

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
severe complication, active infection
Descripción

Active infection or severe complication

Tipo de datos

boolean

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

Concomitant immunotherapy or hormone therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0021083
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0279025
pregnancy or lactation
Descripción

Pregnancy or lactation

Tipo de datos

boolean

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

Eligibility Nasopharyngeal Carcinoma NCT01271439

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Histological Diagnosis of nasopharyngeal carcinoma
Item
histologic diagnosis of nasopharyngeal carcinoma
boolean
C2931822 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
Age group
Item
range from 18～69 years old
boolean
C0001779 (UMLS CUI [1])
TNM Stage
Item
t3-4，n0-2，m0 (ajcc 2009)
boolean
C0441915 (UMLS CUI [1])
KPS Score
Item
kps ≥ 80
boolean
C0206065 (UMLS CUI [1])
Nonmetastatic diseases
Item
nonmetastatic diseases
boolean
C0445092 (UMLS CUI [1])
WBC, hemoglobin and platelet count
Item
wbc count ≥ 4×10^9/l，hemoglobin ≥ 100g/l， platelet count ≥ 100×10^9/l
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Alt, ast and bilirubin
Item
alt or ast ＜ 1.5×uln, bilirubin ＜ 1.5×uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Creatinine
Item
serum creatinine ＜ 1.5×uln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastases
Item
distan metastases
boolean
C1302548 (UMLS CUI [1])
Cancer previously treated with chemotherapy, surgery, immunotherapy, radiotherapy and/or egfr targeted therapy
Item
previously treated (surgery，chemotherapy, radiation therapy，egfr targeted therapy or immunotherapy)
boolean
C2114510 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
C2114510 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C2114510 (UMLS CUI [5,1])
C1739039 (UMLS CUI [5,2])
C2985566 (UMLS CUI [5,3])
Previous malignancy
Item
second malignancy within 5 years
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Previous therapy with investigational agent
Item
previous therapy with an investigational agent
boolean
C2114510 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Uncontrolled seizure or serious neurologic disease
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])
C0205082 (UMLS CUI [2,2])
Allergy to drugs in the study
Item
≥ grade ш allergic reaction to any drug including in this study
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Cardiac or respiratory comorbidity
Item
clinically significant cardiac or respiratory disease
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Creatinine clearance
Item
creatinine clearance < 30ml/min
boolean
C0373595 (UMLS CUI [1])
Substance abuse
Item
drug or alcohol addition
boolean
C0038586 (UMLS CUI [1])
Capacity for civil acts
Item
do not have full capacity for civil acts
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Active infection or severe complication
Item
severe complication, active infection
boolean
C0009450 (UMLS CUI [1])
C3495031 (UMLS CUI [2])
Concomitant immunotherapy or hormone therapy
Item
concurrent immunotherapy or hormone therapy for other diseases
boolean
C2347852 (UMLS CUI [1,1])
C0021083 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
Pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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