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

Sanofi86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Squamous Cell

Interventions

DocetaxelDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Seoul, South Korea

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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