ID

37233

Description

Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02061631

Link

https://clinicaltrials.gov/show/NCT02061631

Keywords

Versions (1)
  1. 7/9/19 7/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of Head and Neck NCT02061631

English

Eligibility Squamous Cell Carcinoma of Head and Neck NCT02061631

1 forms  
Criteria
Description

Criteria

histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage iii-iv without evidence of distant metastases.
Description

Squamous cell carcinoma of the head and neck Advanced Locally Unresectable | Squamous cell carcinoma of the head and neck TNM clinical staging | Squamous cell carcinoma of mouth TNM clinical staging | Distant metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C1519810
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0585362
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C1269798
UMLS CUI [4,2]
C0332197
no prior chemotherapy or radiation therapy.
Description

Prior Chemotherapy Absent | Prior radiation therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0332197
having at least one measurable lesion in one dimension.
Description

Measurable lesion Linear Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
age ≥18 and <65 years with eastern cooperative oncology group ≤ 1.
Description

Age | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
adequate organ function:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
adequate hematological function
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
adequate hepatic function
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
renal function within normal limits
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
peripheral neuropathy > grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
Description

Peripheral Neuropathy CTCAE Grades | Disease Serious | Myocardial Ischemia Unstable | Myocardial Infarction | Nervous system disorder | Mental disorders | Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0030920
being treated concomitantly with corticosteroids (except as pre-medication).
Description

Adrenal Cortex Hormones | Exception Premedication

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0033045
patients having another type of cancer.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
previous chemotherapy or radiotherapy.
Description

Prior Chemotherapy | Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
any previous definitive surgery for squamous cell carcinoma of head and neck.
Description

Operative Surgical Procedures Previous Squamous cell carcinoma of the head and neck

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1168401
severe weight loss (> 20 % of body weight) in the preceding 3 months.
Description

Severe weight loss | Weight decreased Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0041667
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
hearing loss (> grade 2).
Description

Hearing Loss CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C3887873
UMLS CUI [1,2]
C1516728
pregnancy (pregnancy test result for women of childbearing potential).
Description

Pregnancy | Childbearing Potential Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
sexually active females with lack of adequate contraception.
Description

Gender Sexually active | Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332268
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status | Considerations Additional

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Squamous Cell Carcinoma of Head and Neck NCT02061631

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Squamous cell carcinoma of the head and neck Advanced Locally Unresectable | Squamous cell carcinoma of the head and neck TNM clinical staging | Squamous cell carcinoma of mouth TNM clinical staging | Distant metastasis Absent
Item
histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage iii-iv without evidence of distant metastases.
boolean
C1168401 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C1168401 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0585362 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1269798 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Prior Chemotherapy Absent | Prior radiation therapy Absent
Item
no prior chemotherapy or radiation therapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable lesion Linear Quantity
Item
having at least one measurable lesion in one dimension.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Age | ECOG performance status
Item
age ≥18 and <65 years with eastern cooperative oncology group ≤ 1.
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Organ function
Item
adequate organ function:
boolean
C0678852 (UMLS CUI [1])
Hematologic function
Item
adequate hematological function
boolean
C0221130 (UMLS CUI [1])
Liver function
Item
adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
renal function within normal limits
boolean
C0232804 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy CTCAE Grades | Disease Serious | Myocardial Ischemia Unstable | Myocardial Infarction | Nervous system disorder | Mental disorders | Peptic Ulcer
Item
peripheral neuropathy > grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0151744 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
Adrenal Cortex Hormones | Exception Premedication
Item
being treated concomitantly with corticosteroids (except as pre-medication).
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0033045 (UMLS CUI [2,2])
Cancer Other
Item
patients having another type of cancer.
boolean
C1707251 (UMLS CUI [1])
Prior Chemotherapy | Prior radiation therapy
Item
previous chemotherapy or radiotherapy.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Operative Surgical Procedures Previous Squamous cell carcinoma of the head and neck
Item
any previous definitive surgery for squamous cell carcinoma of head and neck.
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1168401 (UMLS CUI [1,3])
Severe weight loss | Weight decreased Percentage Timespan
Item
severe weight loss (> 20 % of body weight) in the preceding 3 months.
boolean
C0041667 (UMLS CUI [1])
C1262477 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Hearing Loss CTCAE Grades
Item
hearing loss (> grade 2).
boolean
C3887873 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential Pregnancy Test
Item
pregnancy (pregnancy test result for women of childbearing potential).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Gender Sexually active | Contraceptive methods Lacking
Item
sexually active females with lack of adequate contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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