ID

12119

Beschreibung

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

Stichworte

Versionen (1)
  1. 24.09.15 24.09.15 - Julian Varghese
Hochgeladen am

24. September 2015

DOI

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Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT02460887

Englisch

Eligibility Nasopharyngeal Carcinoma NCT02460887

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Nasopharyngeal Nonkeratinizing Carcinoma

Datentyp

boolean

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

AJCC tumor staging

Datentyp

boolean

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

satisfactory performance status: karnofsky scale

Datentyp

boolean

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

platelet count; hemoglobin

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

bilirubin; uln

Datentyp

boolean

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

creatinine clearance; renal function

Datentyp

boolean

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

written informed consent.; study

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Basaloid squamous cell carcinoma | Squamous cell carcinoma, keratinizing

Datentyp

boolean

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

palliative; treatment; intent

Datentyp

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.
Beschreibung

prior malignancy; cervical; squamous; cancer; skin

Datentyp

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).
Beschreibung

Patient currently pregnant | Lactating (finding)

Datentyp

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).
Beschreibung

history of previous rt

Datentyp

boolean

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

prior chemotherapy; primary tumor; surgery; nodes

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT02460887

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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