ID

31689

Beschrijving

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

Trefwoorden

Versies (2)
  1. 16-09-18 16-09-18 -
  2. 21-09-18 21-09-18 -
Houder van rechten

Sun Yat-sen University

Geüploaded op

21 september 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01271439

Engels

Eligibility Nasopharyngeal Carcinoma NCT01271439

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of nasopharyngeal carcinoma
Beschrijving

Histological Diagnosis of nasopharyngeal carcinoma

Datatype

boolean

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

Age group

Datatype

boolean

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

TNM Stage

Datatype

boolean

Alias
UMLS CUI [1]
C0441915
kps ≥ 80
Beschrijving

KPS Score

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
nonmetastatic diseases
Beschrijving

Nonmetastatic diseases

Datatype

boolean

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

WBC, hemoglobin and platelet count

Datatype

boolean

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

Alt, ast and bilirubin

Datatype

boolean

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

Creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
distan metastases
Beschrijving

Distant metastases

Datatype

boolean

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

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

Datatype

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
Beschrijving

Previous malignancy

Datatype

boolean

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

Previous therapy with investigational agent

Datatype

boolean

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

Uncontrolled seizure or serious neurologic disease

Datatype

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
Beschrijving

Allergy to drugs in the study

Datatype

boolean

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

Cardiac or respiratory comorbidity

Datatype

boolean

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

Creatinine clearance

Datatype

boolean

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

Substance abuse

Datatype

boolean

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

Capacity for civil acts

Datatype

boolean

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

Active infection or severe complication

Datatype

boolean

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

Concomitant immunotherapy or hormone therapy

Datatype

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
Beschrijving

Pregnancy or lactation

Datatype

boolean

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

Eligibility Nasopharyngeal Carcinoma NCT01271439

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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