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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:
To estimate:
To analyze:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOCETAXEL(XRP6976) | Drug | docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle |
|
| Measure | Description | 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) |
| Measure | Description | 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 |
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Inclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Christian Fassotte | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Algiers | Algeria | ||||
| Sanofi-Aventis Administrative Office |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| Casablanca |
| Morocco |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |