ID

31692

Beschreibung

A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01479504 Collaborating Parties: People's Hospital of Guangxi 303rd Hospital of the People's Liberation Army Nanning Second People's Hospital Guangxi Traditional Chinese Medical University Guilin Medical College Guangxi Naxishan Hospital Liuzhou Worker's Hospital Liuzhou People's Hospital Liuzhou Hospital of Traditional Chinese Medicine Liuzhou Cancer Hospital Liuzhou Railway hospital First People's Hospital of Yulin The Red Cross hospital of YuLin Guigang People's Hospital Wuzhou Red Cross Hospital

Link

https://clinicaltrials.gov/show/NCT01479504

Stichworte

Versionen (1)
  1. 21.09.18 21.09.18 -
Rechteinhaber

Guangxi Medical University

Hochgeladen am

21. September 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01479504

Englisch

Eligibility Nasopharyngeal Carcinoma NCT01479504

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
Beschreibung

histological diagnosis of nasopharyngeal carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2931822
UMLS CUI [1,2]
C0449575
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0439807
non-keratinizing or undifferentiated type
Beschreibung

Non-keratinizing or undifferentiated carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1334926
UMLS CUI [2,1]
C2931822
UMLS CUI [2,2]
C0205698
clinical stage iii-ivb (uicc 7th edition)
Beschreibung

Clinical stage UICC

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441914
UMLS CUI [1,2]
C0205210
age between 18-70
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
satisfactory performance status: karnofsky scale (kps) > 70.
Beschreibung

Karnofsky performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
hemoglobin > 100g/l, wbc > 4.0x10*9/l, plt > 100x10*9/l
Beschreibung

Hemoglobin, wbc, platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
serum creatinine level < 1.6 mg/dl or creatinine clearance ≥ 60 ml/min.
Beschreibung

serum creatinine, creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
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 ≤1.5uln
Beschreibung

ALT, AST, ALP, Bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201913
patients must be informed of the investigational nature of this study and give written informed consent.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
anticipated life span more than 6 month
Beschreibung

Life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary treatment with palliative intent
Beschreibung

Palliative intent

Datentyp

boolean

Alias
UMLS CUI [1]
C1285530
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
Beschreibung

Keratinizing or basaloid squamous cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301142
UMLS CUI [1,2]
C0334247
UMLS CUI [1,3]
C1266005
UMLS CUI [2,1]
C1301142
UMLS CUI [2,2]
C1266005
UMLS CUI [2,3]
C1266005
Evidence of distant metastases
Beschreibung

Status of distant metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C1302548
pregnancy or lactation
Beschreibung

Pregnancy or lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of previous radiotherapy (except for non-melanomatous skin cancers outside intended rt treatment volume).
Beschreibung

Previous radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2114510
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0007114
UMLS CUI [2,3]
C1518408
UMLS CUI [2,4]
C1522449
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
Beschreibung

Prior chemotherapy or surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0597029
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
Beschreibung

Prior malignancies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332132
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0332154
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0007137
UMLS CUI [3,3]
C0332154
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0278587
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0242793
UMLS CUI [5,4]
C3843495
any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×uln), and emotional disturbance.
Beschreibung

Comorbidity or other medical contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0019189
UMLS CUI [5]
C0421258
UMLS CUI [6]
C0013985
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT01479504

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
histological diagnosis of nasopharyngeal carcinoma
Item
histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
boolean
C2931822 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
Non-keratinizing or undifferentiated carcinoma
Item
non-keratinizing or undifferentiated type
boolean
C1334926 (UMLS CUI [1])
C2931822 (UMLS CUI [2,1])
C0205698 (UMLS CUI [2,2])
Clinical stage UICC
Item
clinical stage iii-ivb (uicc 7th edition)
boolean
C0441914 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Age
Item
age between 18-70
boolean
C0001779 (UMLS CUI [1])
Karnofsky performance status
Item
satisfactory performance status: karnofsky scale (kps) > 70.
boolean
C0206065 (UMLS CUI [1])
Hemoglobin, wbc, platelet count
Item
hemoglobin > 100g/l, wbc > 4.0x10*9/l, plt > 100x10*9/l
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
serum creatinine, creatinine clearance
Item
serum creatinine level < 1.6 mg/dl or creatinine clearance ≥ 60 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
ALT, AST, ALP, 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 ≤1.5uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
Informed consent
Item
patients must be informed of the investigational nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Life expectancy
Item
anticipated life span more than 6 month
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Palliative intent
Item
primary treatment with palliative intent
boolean
C1285530 (UMLS CUI [1])
Keratinizing or basaloid squamous cell carcinoma
Item
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
boolean
C1301142 (UMLS CUI [1,1])
C0334247 (UMLS CUI [1,2])
C1266005 (UMLS CUI [1,3])
C1301142 (UMLS CUI [2,1])
C1266005 (UMLS CUI [2,2])
C1266005 (UMLS CUI [2,3])
Status of distant metastases
Item
Evidence of distant metastases
boolean
C1302548 (UMLS CUI [1])
Pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Previous radiotherapy
Item
history of previous radiotherapy (except for non-melanomatous skin cancers outside intended rt treatment volume).
boolean
C1522449 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0007114 (UMLS CUI [2,2])
C1518408 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
Prior chemotherapy or surgery
Item
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
boolean
C1514457 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0597029 (UMLS CUI [2,2])
Prior malignancies
Item
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0332154 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
C0332154 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0278587 (UMLS CUI [4,2])
C0332300 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0242793 (UMLS CUI [5,3])
C3843495 (UMLS CUI [5,4])
Comorbidity or other medical contraindication
Item
any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×uln), and emotional disturbance.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0019189 (UMLS CUI [4])
C0421258 (UMLS CUI [5])
C0013985 (UMLS CUI [6])
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