ID

12119

Description

The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT; ODM derived from: https://clinicaltrials.gov/show/NCT02460887

Link

https://clinicaltrials.gov/show/NCT02460887

Keywords

Versions (1)
  1. 9/24/15 9/24/15 - Julian Varghese
Uploaded on

September 24, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02460887

English

Eligibility Nasopharyngeal Carcinoma NCT02460887

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including who ii or iii).
Description

Nasopharyngeal Nonkeratinizing Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1334926
tumor staged as t1-4n2-3或t3-4n0-1m0 (according to the 7th ajcc edition).
Description

AJCC tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0441915
satisfactory performance status: karnofsky scale (kps) ≥ 70.
Description

satisfactory performance status: karnofsky scale

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥
Description

platelet count; hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
adequate liver function: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln
Description

alkaline phosphatase; concomitant; normal; liver; upper; ast; uln

Data type

boolean

Alias
UMLS CUI [1]
C0376147
UMLS CUI [2]
C0242192
UMLS CUI [3]
C0201850
and bilirubin ≤1.5×uln.
Description

bilirubin; uln

Data type

boolean

Alias
UMLS CUI [1]
C1278039
adequate renal function: creatinine clearance ≥ 60 ml/min.
Description

creatinine clearance; renal function

Data type

boolean

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

written informed consent.; study

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Basaloid squamous cell carcinoma | Squamous cell carcinoma, keratinizing

Data type

boolean

Alias
UMLS CUI [1]
C1266005
UMLS CUI [2]
C0334247
treatment with palliative intent.
Description

palliative; treatment; intent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1285530
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Description

prior malignancy; cervical; squamous; cancer; skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
Description

Patient currently pregnant | Lactating (finding)

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
Description

history of previous rt

Data type

boolean

Alias
UMLS CUI [1]
C1522449
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Description

prior chemotherapy; primary tumor; surgery; nodes

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0038894
UMLS CUI [2,2]
C0006826
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.
Description

Disease condition determination, uncontrolled | Compliance behavior | Heart Diseases; Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Emotional Disturbances

Data type

boolean

Alias
UMLS CUI [1]
C0184774
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0019189
UMLS CUI [6]
C0860161
UMLS CUI [7]
C0013985
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT02460887

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal Nonkeratinizing Carcinoma
Item
patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including who ii or iii).
boolean
C1334926 (UMLS CUI [1])
AJCC tumor staging
Item
tumor staged as t1-4n2-3或t3-4n0-1m0 (according to the 7th ajcc edition).
boolean
C0441915 (UMLS CUI [1])
satisfactory performance status: karnofsky scale
Item
satisfactory performance status: karnofsky scale (kps) ≥ 70.
boolean
C1520224 (UMLS CUI [1])
platelet count; hemoglobin
Item
adequate marrow: leucocyte count ≥ 4000/μl, hemoglobin ≥ 90g/l and platelet count ≥
boolean
C0023508 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
alkaline phosphatase; concomitant; normal; liver; upper; ast; uln
Item
adequate liver function: alanine aminotransferase (alt), aspartate aminotransferase (ast) < 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln
boolean
C0376147 (UMLS CUI [1])
C0242192 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
bilirubin; uln
Item
and bilirubin ≤1.5×uln.
boolean
C1278039 (UMLS CUI [1])
creatinine clearance; renal function
Item
adequate renal function: creatinine clearance ≥ 60 ml/min.
boolean
C0373595 (UMLS CUI [1])
written informed consent.; study
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)
Basaloid squamous cell carcinoma | Squamous cell carcinoma, keratinizing
Item
who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
boolean
C1266005 (UMLS CUI [1])
C0334247 (UMLS CUI [2])
palliative; treatment; intent
Item
treatment with palliative intent.
boolean
C0087111 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
prior malignancy; cervical; squamous; cancer; skin
Item
prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
boolean
C0006826 (UMLS CUI [1])
Patient currently pregnant | Lactating (finding)
Item
pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
history of previous rt
Item
history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume).
boolean
C1522449 (UMLS CUI [1])
prior chemotherapy; primary tumor; surgery; nodes
Item
prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
boolean
C0392920 (UMLS CUI [1])
C0038894 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Disease condition determination, uncontrolled | Compliance behavior | Heart Diseases; Unstable status | Kidney Diseases | Hepatitis, Chronic | Diabetes mellitus poor control | Emotional Disturbances
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
C0184774 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4])
C0019189 (UMLS CUI [5])
C0860161 (UMLS CUI [6])
C0013985 (UMLS CUI [7])
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