TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel

Criteria

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.