TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
Phase 3
Completed
- Conditions
- Carcinoma, Squamous Cell
- Registration Number
- NCT00539630
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇰🇷Seoul, Korea, Republic of