ID

12911

Description

Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT00139269

Link

https://clinicaltrials.gov/show/NCT00139269

Keywords

  1. 1/6/16 1/6/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 6, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Advanced Squamous Cell Carcinoma NCT00139269

Eligibility Advanced Squamous Cell Carcinoma NCT00139269

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (sschn).
Description

Diagnosis of squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007137
at least one bi- or uni-dimensionally measurable lesion.
Description

Lesion

Data type

boolean

Alias
UMLS CUI [1]
C0221198
stage ii or iv disease without evidence of distant metastasis.
Description

Stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn.
Description

Prior therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
age greater than 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 or 1.
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of greater than 12 weeks.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow, hepatic and renal function.
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
normal serum calcium
Description

Calcium

Data type

boolean

Alias
UMLS CUI [1]
C0201925
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
Description

Tumor location

Data type

boolean

Alias
UMLS CUI [1]
C0872338
patients with any non-sschn malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
Description

Other malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
any prior treatment with chemotherapy.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
current peripheral neuropathy of greater than nci grade 2.
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
other serious illness or medical condition
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
concurrent treatment with corticosteroids unless chronic treatment at low doses.
Description

corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0001617
pregnant or lactating females or females of childbearing potential not employing adequate contraception.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Advanced Squamous Cell Carcinoma NCT00139269

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis of squamous cell carcinoma
Item
histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (sschn).
boolean
C0007137 (UMLS CUI [1])
Lesion
Item
at least one bi- or uni-dimensionally measurable lesion.
boolean
C0221198 (UMLS CUI [1])
Stage
Item
stage ii or iv disease without evidence of distant metastasis.
boolean
C1300072 (UMLS CUI [1])
Prior therapy
Item
no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn.
boolean
C0087111 (UMLS CUI [1])
Age
Item
age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of greater than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate bone marrow, hepatic and renal function.
boolean
C0678852 (UMLS CUI [1])
Calcium
Item
normal serum calcium
boolean
C0201925 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor location
Item
primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
boolean
C0872338 (UMLS CUI [1])
Other malignancies
Item
patients with any non-sschn malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
boolean
C0006826 (UMLS CUI [1])
chemotherapy
Item
any prior treatment with chemotherapy.
boolean
C0392920 (UMLS CUI [1])
radiotherapy
Item
prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
boolean
C1522449 (UMLS CUI [1])
peripheral neuropathy
Item
current peripheral neuropathy of greater than nci grade 2.
boolean
C0031117 (UMLS CUI [1])
Comorbidity
Item
other serious illness or medical condition
boolean
C0009488 (UMLS CUI [1])
corticosteroids
Item
concurrent treatment with corticosteroids unless chronic treatment at low doses.
boolean
C0001617 (UMLS CUI [1])
Pregnancy
Item
pregnant or lactating females or females of childbearing potential not employing adequate contraception.
boolean
C0032961 (UMLS CUI [1])

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