ID

31757

Descripción

Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01245959

Link

https://clinicaltrials.gov/show/NCT01245959

Palabras clave

Versiones (1)
  1. 26/9/18 26/9/18 -
Titular de derechos de autor

Jun Ma, Sun Yat-sen University

Subido en

26 de septiembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01245959

Inglés

Eligibility Nasopharyngeal Carcinoma NCT01245959

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly histologically confirmed non-keratinizing (according to world health organization (who) histologically type).
Descripción

Histologically confirmed (nasopharyngeal) non-keratinizing (WHO criteria)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1334926
UMLS CUI [1,2]
C1518321
UMLS CUI [2]
C1301142
tumor staged as t3-4n1/n2-3 (according to the 7th american joint commission on cancer edition).
Descripción

Tumor stage (american joint commission on cancer)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0441915
no evidence of distant metastasis (m0).
Descripción

No distant metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1302548
satisfactory performance status: karnofsky scale (kps) > 70.
Descripción

KPS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl.
Descripción

Leukocyte, Hemoglobin, Platelet count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0005821
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 ≤uln.
Descripción

ALT, AST, alkaline phosphatase, bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
adequate renal function: creatinine clearance ≥60 ml/min.
Descripción

Creatinin clearance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
patients must be informed of the investigational nature of this study and give written informed consent.
Descripción

Information about investigation of study, written informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Descripción

WHO type keratinizing/basaloid squamous cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0334247
UMLS CUI [1,2]
C1301142
UMLS CUI [2,1]
C1266005
UMLS CUI [2,2]
C1301142
age ≥60 years or <18 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
treatment with palliative intent.
Descripción

Palliative treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1285530
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Descripción

Prior malignancy except treated basal/squamous cell cancer, cervical cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0007137
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0851140
pregnancy or lactation.
Descripción

Pregnancy or lactation

Tipo de datos

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).
Descripción

Prior radiotherapy except for non-melanomatous skin cancers

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C1522449
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C1518408
UMLS CUI [2,4]
C0007114
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Descripción

Prior chemotherapy/surgery to primary tumor/nodes (except diagnostic)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0744961
UMLS CUI [2,2]
C0677930
UMLS CUI [3,1]
C0744961
UMLS CUI [3,2]
C0024204
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0430022
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.
Descripción

Severe intercurrent disease bringing risk/affectin compliance (unstable cardiac disease, renal disease, chronic hepatitis, diabetes, emotional disturbance)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1883420
UMLS CUI [2,4]
C0035647
UMLS CUI [3,1]
C0443343
UMLS CUI [3,2]
C0018799
UMLS CUI [3,3]
C0815189
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0019189
UMLS CUI [6,1]
C0011847
UMLS CUI [6,2]
C0583513
UMLS CUI [7]
C0004936
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT01245959

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Histologically confirmed (nasopharyngeal) non-keratinizing (WHO criteria)
Item
patients with newly histologically confirmed non-keratinizing (according to world health organization (who) histologically type).
boolean
C1334926 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C1301142 (UMLS CUI [2])
Tumor stage (american joint commission on cancer)
Item
tumor staged as t3-4n1/n2-3 (according to the 7th american joint commission on cancer edition).
boolean
C0441915 (UMLS CUI [1])
No distant metastasis
Item
no evidence of distant metastasis (m0).
boolean
C1298908 (UMLS CUI [1,1])
C1302548 (UMLS CUI [1,2])
KPS
Item
satisfactory performance status: karnofsky scale (kps) > 70.
boolean
C0206065 (UMLS CUI [1])
Leukocyte, Hemoglobin, Platelet count
Item
adequate marrow: leucocyte count ≥4000/μl, hemoglobin ≥90g/l and platelet count ≥100000/μl.
boolean
C0023508 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
ALT, AST, alkaline phosphatase, 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 ≤uln.
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Creatinin clearance
Item
adequate renal function: creatinine clearance ≥60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Information about investigation of study, written informed consent
Item
patients must be informed of the investigational nature of this study and give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
WHO type keratinizing/basaloid squamous cell carcinoma
Item
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
boolean
C0334247 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C1266005 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
Age
Item
age ≥60 years or <18 years.
boolean
C0001779 (UMLS CUI [1])
Palliative treatment
Item
treatment with palliative intent.
boolean
C1285530 (UMLS CUI [1])
Prior malignancy except treated basal/squamous cell cancer, cervical cancer
Item
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
boolean
C0006826 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior radiotherapy except for non-melanomatous skin cancers
Item
history of previous radiotherapy (except for non-melanomatous skin cancers outside intended rt treatment volume).
boolean
C0332152 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1518408 (UMLS CUI [2,3])
C0007114 (UMLS CUI [2,4])
Prior chemotherapy/surgery to primary tumor/nodes (except diagnostic)
Item
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
boolean
C1514457 (UMLS CUI [1])
C0744961 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0744961 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0430022 (UMLS CUI [4,2])
Severe intercurrent disease bringing risk/affectin compliance (unstable cardiac disease, renal disease, chronic hepatitis, diabetes, emotional disturbance)
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])
C0392760 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1883420 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
C0443343 (UMLS CUI [3,1])
C0018799 (UMLS CUI [3,2])
C0815189 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4])
C0019189 (UMLS CUI [5])
C0011847 (UMLS CUI [6,1])
C0583513 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7])
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