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

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.

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Key information

Conditions

Carcinoma, Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start: 2002
First posted: Oct 4, 2007
Registry last updated: Oct 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed