ID

39345

Description

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

Link

https://clinicaltrials.gov/show/NCT01425736

Keywords

  1. 12/23/19 12/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 23, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

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

Data type

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 .
Description

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

Data type

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.
Description

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Gender | At risk of unplanned pregnancy Contraceptive method

Data type

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
Description

Hemoglobin measurement | White Blood Cell Count procedure

Data type

boolean

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

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

Data type

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
Description

Renal function | Creatinine measurement, serum

Data type

boolean

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

Exclusion Criteria

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

Anti-EGFR monoclonal antibody therapy

Data type

boolean

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

Study Subject Participation Status | Interventional procedure

Data type

boolean

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

Pharmacotherapy Other | Operative Surgical Procedure Other

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Hypersensitivity Serious

Data type

boolean

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

Lung disease Serious | Disorder of head Serious

Data type

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
Description

Cancer Other

Data type

boolean

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

Neoplasm Except Primary tumor

Data type

boolean

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

Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT01425736

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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