Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective:
To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.
Secondary objective:
To assess tumor control and survival
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Neo-adjuvant Taxotere followed by cisplatin and radiotherapy |
|
| 2 | Active Comparator | Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m² |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate. | From administration of drug to end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | From administration of drug to end of study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iris Chan | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Hong Kong | Hong Kong |
Not provided
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
75 mg/m² |
|
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |