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])
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])