TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
This study has been completed.
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First received: October 3, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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Further study details as provided by Sanofi:
Primary Outcome Measures:
- Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed [ Time Frame: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy. ]
Secondary Outcome Measures:
- 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.
|Study Start Date:||November 2002|
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