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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Squamous Cell

Treatments: Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00539630

XRP6976F_3501

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)