Carcinoma, Squamous Cell
Conditions
Brief summary
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.
Interventions
DRUGDocetaxel
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease. * Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx. * Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion. * WHO performance status 0 or 1. * Adequate bone marrow, hepatic and renal functions.
Exclusion criteria
* Pregnant and lactating women * Previous chemotherapy * Previous radiotherapy for H&N * Previous surgery for H&N 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 |
|---|---|
| Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed | After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy. |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate. | — |
Countries
South Korea
Outcome results
None listed