ID

29439

Beschreibung

Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC); ODM derived from: https://clinicaltrials.gov/show/NCT00805012

Link

https://clinicaltrials.gov/show/NCT00805012

Stichworte

Versionen (1)
  1. 24.03.18 24.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

Englisch

Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed hnscc
Beschreibung

Squamous cell carcinoma of the head and neck

Datentyp

boolean

Alias
UMLS CUI [1]
C1168401
adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
Beschreibung

Primary tumor site | Oral cavity | Oropharynx | Hypopharynx | Nasal cavity | Nasal sinus | Head Neck Site | Exception Nasopharynx

Datentyp

boolean

Alias
UMLS CUI [1]
C0475447
UMLS CUI [2]
C0226896
UMLS CUI [3]
C0521367
UMLS CUI [4]
C0020629
UMLS CUI [5]
C0027423
UMLS CUI [6]
C0030471
UMLS CUI [7,1]
C0460004
UMLS CUI [7,2]
C1515974
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0027442
at least one measurable lesion
Beschreibung

Measurable lesion Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
Beschreibung

Chemotherapy Palliative Absent | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1285530
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [4]
C1522449
18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate laboratory result
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
written, informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
experimental drug clinical trial within 30 days
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
other malignancy (exemption: treated basal cell carcinoma of skin, cis, cured cancer with disease-free interval with more than 5 years)
Beschreibung

Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in Situ | Exception Malignant Neoplasm Cured | Exception Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1880198
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
patient with organ transplantation
Beschreibung

Organ Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
grade 2 or more peripheral neuropathy
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
grade 2 or more hearing loss
Beschreibung

Hearing Loss CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3887873
UMLS CUI [1,2]
C1516728
severe, medical condition
Beschreibung

Medical condition Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck
Item
histologically confirmed hnscc
boolean
C1168401 (UMLS CUI [1])
Primary tumor site | Oral cavity | Oropharynx | Hypopharynx | Nasal cavity | Nasal sinus | Head Neck Site | Exception Nasopharynx
Item
adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
boolean
C0475447 (UMLS CUI [1])
C0226896 (UMLS CUI [2])
C0521367 (UMLS CUI [3])
C0020629 (UMLS CUI [4])
C0027423 (UMLS CUI [5])
C0030471 (UMLS CUI [6])
C0460004 (UMLS CUI [7,1])
C1515974 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0027442 (UMLS CUI [8,2])
Measurable lesion Quantity
Item
at least one measurable lesion
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Chemotherapy Palliative Absent | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Therapeutic radiology procedure
Item
no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
boolean
C0392920 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog 0 or 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results
Item
adequate laboratory result
boolean
C1254595 (UMLS CUI [1])
Informed Consent
Item
written, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative
Item
pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
experimental drug clinical trial within 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Carcinoma in Situ | Exception Malignant Neoplasm Cured | Exception Disease Free of
Item
other malignancy (exemption: treated basal cell carcinoma of skin, cis, cured cancer with disease-free interval with more than 5 years)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Organ Transplantation
Item
patient with organ transplantation
boolean
C0029216 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
grade 2 or more peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hearing Loss CTCAE Grades
Item
grade 2 or more hearing loss
boolean
C3887873 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Medical condition Severe
Item
severe, medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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