Head and Neck Neoplasms
Conditions
Brief summary
Primary Objective: To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT. Secondary Objectives: To evaluate: * The radiological response after chemotherapy and radiotherapy * The pathological response after chemotherapy by cavum biopsy To estimate: * The duration of overall response * The time to progression (T.T.P) To analyze: * The overall survival * The safety profile
Interventions
DRUGDOCETAXEL(XRP6976)
docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Written or witnessed oral informed consent prior to beginning specific protocol procedures \>Histologically proven undifferentiated carcinoma of nasopharyngeal type (UCNT- stage II-III OMS) at first diagnosis * Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T, N2 - N3 UCNT, without metastasis * Adenopathy \> 3 cm * Patients are required to have an unidimensionally measurable disease with RECIST method * Performance status 1 or karnofsky index 3 * Previous therapy: Chemotherapy :none Radiation therapy: none Surgery: none * Laboratory requirements
Exclusion criteria
* Prior chemotherapy or / and radiotherapy * Metastatic disease (M as per the UCCI/AJC classification) * Past or current history of neoplasm other than UCNT, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years * Pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation * Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI criteria * Others serious illness or medical condition: 1.Congestive heart failure or unstable angina pectoris even if it is medically controlled 2.Previous history of myocardial infraction within 1 year from study entry 3.Uncontrolled hypertension or high risk uncontrolled arrhythmias 4.Uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate any use of corticoids 5.Concomitant treatment with corticoids initiated \> 6 months prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg 6.Definite contraindications for the use of Corticoids 7.Concurrent treatment with other experimental drugs 8.Participation in another clinical with any investigational drug within 30 days prior to study entry 9.Performance status = 2,3,4 or karnofsky index \< 80 10. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of tumor response in patients with measurable disease according to RECIST criteria | on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy) |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the radiological response after chemotherapy and radiotherapy | from baseline to the end of the study |
| Evaluation of the pathological response after chemotherapy | between day 64 and day 71 of the treatment |
| Overall response duration | from baseline to the end of the study |
| Estimation of the time to progression | from baseline to the end of the study |
| Overall survival | from baseline to the end of the study |
Countries
Algeria, Morocco, Tunisia
Outcome results
None listed