ID

39345

Beskrivning

Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01425736

Länk

https://clinicaltrials.gov/show/NCT01425736

Nyckelord

Versioner (1)
  1. 2019-12-23 2019-12-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

Engelsk

Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
joined the study voluntary and signed informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
age 18-75，both genders.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
Beskrivning

Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC

Datatyp

boolean

Alias
UMLS CUI [1]
C4524839
UMLS CUI [2]
C0744620
at least one lesions can be measured,conventional measurements ≥2cm, computed tomography(ct) examination ≥1cm .
Beskrivning

Measurable Disease Quantity | Lesion size Measurement conventional | Lesion size Computed Tomography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C0439858
UMLS CUI [3,1]
C0449453
UMLS CUI [3,2]
C0040405
eastern cooperative oncology group(ecog) performance scale 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of more than 3 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
Beskrivning

Gender | At risk of unplanned pregnancy Contraceptive method

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3839721
UMLS CUI [2,2]
C0700589
haemoglobin≥90g/l ,white blood cell(wbc) ≥3×10^9/l
Beskrivning

Hemoglobin measurement | White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
hepatic function:alat、asat< 2.5 x uln, tbil< 1.5 x uln
Beskrivning

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
renal function: creatinine < 1.5 x uln
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received other anti egfr monoclonal antibody treatment
Beskrivning

Anti-EGFR monoclonal antibody therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C4316122
participation in other interventional clinical trials within 1 month
Beskrivning

Study Subject Participation Status | Interventional procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
previous received other drug or operative treatment within 6 month
Beskrivning

Pharmacotherapy Other | Operative Surgical Procedure Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205394
pregnant or breast-feeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of serious allergic or allergy
Beskrivning

Hypersensitivity Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205404
patients with the history of serious lung or head disease
Beskrivning

Lung disease Serious | Disorder of head Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1290856
UMLS CUI [2,2]
C0205404
other malignant tumor
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
not primary tumor(except for primary tumor therapy>3months)
Beskrivning

Neoplasm Except Primary tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0677930
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
joined the study voluntary and signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
age 18-75，both genders.
boolean
C0001779 (UMLS CUI [1])
Recurrent Head and Neck Squamous Cell Carcinoma | HEAD NECK CANCER SQUAMOUS CELL METASTATIC
Item
had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
boolean
C4524839 (UMLS CUI [1])
C0744620 (UMLS CUI [2])
Measurable Disease Quantity | Lesion size Measurement conventional | Lesion size Computed Tomography
Item
at least one lesions can be measured,conventional measurements ≥2cm, computed tomography(ct) examination ≥1cm .
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0439858 (UMLS CUI [2,3])
C0449453 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance scale 0-2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of more than 3 months.
boolean
C0023671 (UMLS CUI [1])
Gender | At risk of unplanned pregnancy Contraceptive method
Item
use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
boolean
C0079399 (UMLS CUI [1])
C3839721 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Hemoglobin measurement | White Blood Cell Count procedure
Item
haemoglobin≥90g/l ,white blood cell(wbc) ≥3×10^9/l
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
hepatic function:alat、asat< 2.5 x uln, tbil< 1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
renal function: creatinine < 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Anti-EGFR monoclonal antibody therapy
Item
received other anti egfr monoclonal antibody treatment
boolean
C4316122 (UMLS CUI [1])
Study Subject Participation Status | Interventional procedure
Item
participation in other interventional clinical trials within 1 month
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
Pharmacotherapy Other | Operative Surgical Procedure Other
Item
previous received other drug or operative treatment within 6 month
boolean
C0013216 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Serious
Item
history of serious allergic or allergy
boolean
C0020517 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Lung disease Serious | Disorder of head Serious
Item
patients with the history of serious lung or head disease
boolean
C0024115 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1290856 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Cancer Other
Item
other malignant tumor
boolean
C1707251 (UMLS CUI [1])
Neoplasm Except Primary tumor
Item
not primary tumor(except for primary tumor therapy>3months)
boolean
C0027651 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
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