Eligibility Oral Squamous Cell Carcinoma NCT01772706

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StudyEvent: Eligibility
1. Eligibility Oral Squamous Cell Carcinoma NCT01772706

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

1. age between 18 and 75 years

boolean

C0001779 (UMLS CUI [1])

Squamous cell carcinoma of mouth TNM clinical staging | Squamous cell carcinoma of oropharynx TNM clinical staging | Squamous cell carcinoma of the hypopharynx TNM clinical staging

Item

2. patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage iii-iv, histologically confirmed

boolean

C0585362 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0280313 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0280321 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])

Performance status

Item

3. ps > or = 2

boolean

C1518965 (UMLS CUI [1])

Life Expectancy | Therapeutic procedure Absent

Item

4. estimated life expectancy greater than 3 months in the absence of treatment

boolean

C0023671 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])

Chemotherapy

Item

5. concomitant chemotherapy with one of the following choices not prohibited:

boolean

C0392920 (UMLS CUI [1])

cetuximab

Item

cetuximab alone

boolean

C0995188 (UMLS CUI [1])

Fluorouracil | Combined Modality Therapy | Carboplatin | Cisplatin

Item

5-fu combined to carboplatin or cisplatin

boolean

C0016360 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0079083 (UMLS CUI [3])
C0008838 (UMLS CUI [4])

Cisplatin | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Item

cisplatin alone being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the cockcroft method) in case of serum creatinine > 120 µmol/l

boolean

C0008838 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])

Hematologic function | Renal function | Liver function

Item

6. appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:

boolean

C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])

Hemoglobin measurement

Item

hemoglobin> 8g/dl

boolean

C0518015 (UMLS CUI [1])

Neutrophil count

Item

neutrophils> 1500 x 109 / l

boolean

C0200633 (UMLS CUI [1])

Platelet Count measurement

Item

platelets> 100 x 109 / l

boolean

C0032181 (UMLS CUI [1])

Serum total bilirubin measurement

Item

total bilirubin <1.5 times the upper limit of normal

boolean

C1278039 (UMLS CUI [1])

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Item

alt / ast and alkaline phosphatase <2.5 times the upper limit of normal.

boolean

C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices

Item

7. for women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.

boolean

C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Item

1. presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix

boolean

C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])

Chemotherapy Neoadjuvant

Item

2. neoadjuvant chemotherapy

boolean

C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])

Neoplasm Metastasis

Item

3. metastatic disease

boolean

C0027627 (UMLS CUI [1])

Radiotherapy to head and neck

Item

4. previous treatment with ent radiotherapy

boolean

C3888854 (UMLS CUI [1])

Severe allergy Platinum-based Drug

Item

5. severe hypersensitivity known to platinum based agent

boolean

C2945656 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])

Pathology Uncontrolled | Respiration Disorder Uncontrolled | Heart Disease Uncontrolled | Liver disease Uncontrolled | Kidney Disease Uncontrolled

Item

6. any uncontrolled pathology (respiratory, cardiac, hepatic or renal)

boolean

C0677042 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0022658 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Item

7. pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])

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Eligibility Oral Squamous Cell Carcinoma NCT01772706