An Open Label, Randomized Multicenter Study of Neoadjuvant Docetaxel+Cisplatin +5-fluorouracil Versus Neoadjuvant Cisplatin+5-fluorouracil in Chinese Patients With Locally Advanced Inoperable SCHHN.
- Tumor type: Histologically or cytologically proven squamous cell carcinoma of the
head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary
tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx.
- Extent of the disease:
- Patients are required to have at least one measurable lesion.
- Stage III or IV without evidence of distant metastases, according to the TNM
staging system. Absence of metastases must be checked by chest X-ray (with or
without Computed tomography (CT) ), abdominal ultrasound or CT in case of liver
function test abnormalities, and bone scan in case of local symptoms.
- Tumor considered as inoperable after evaluation by a multidisciplinary team.
Reason for inoperability will be reported in the CRF
- World Health Organization (WHO) performance status 0 or 1
- Laboratory data:
- Neutrophil count > or = 2.0*10^9/L
- Platelet count > or = 100*10^9/L
- Hemoglobin > or = 10 g/dl (6.2 mmol/L)
- Hepatic function:
- Total serum bilirubin < or = 1 time the upper normal limit (UNL) of the participating
- Aspartate transaminase (ASAT/SGOT) and Alanine transaminase (ALAT/SGPT) < or = 2.5UNL
- Alkaline phosphatase < or = 5 UNL
- Patients with ASAT or ALAT > 1.5UNL associated with alkaline phosphatase >2.5UNL are
not eligible for the study
- Renal function:
- serum creatinine < or = 120µmol/L (1.4 mg/dl) if values are >120µmol/L, creatinine
clearance should be > or = 60 ml/min
- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule,
those conditions should be discussed with the patient before registration in the
- Patients informed consent form obtained
- Tumors of the nasopharynx, the nasal and paranasal cavities.
- Previous chemotherapy or radiotherapy for any reason and previous surgery for SCCHN
at time of study entry.
- Prior treatment within a therapeutic clinical tria within 30 days prior to study
- Concurrent treatment with any other anticancer therapy
- Chronic treatment (> or = 3 months) with corticosteroids at a daily dose > or = 20mg
methylprednisolone or equivalent.
- Concomitant use of drugs which could interact with 5-fluorouracil (e.g. cimetidine,
allopurinol, folic or folinic acid)
- Previous or current malignancies at other sites with the exception of adequately
treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of
the skin or other cancer curatively treated by surgery and with no evidence of
disease for at least 5 years
- Symptomatic peripheral neuropathy > or = grade 2 by NCIC-CTG criteria
- Clinical altered hearing
- Pregnant, lactating women or of childbearing potential unless adequate
- with other serious illness or medical condition including but not limited to:
- unstable cardiac disease despite treatment
- myocardial infarction within 6 months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or
- active uncontrolled infection
- active peptic ulcer
- chronic obstructive pulmonary disease requiring hospitalization during the year
preceding study entry
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.