ID

29439

Descrição

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

Palavras-chave

  1. 24/03/2018 24/03/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de março de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed hnscc
Descrição

Squamous cell carcinoma of the head and neck

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

Measurable lesion Quantity

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate laboratory result
Descrição

Laboratory Results

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

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)
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative

Tipo de dados

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
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Organ Transplantation

Tipo de dados

boolean

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

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

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

Hearing Loss CTCAE Grades

Tipo de dados

boolean

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

Medical condition Severe

Tipo de dados

boolean

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

Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT00805012

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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