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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Squamous Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hyang Rim Kim

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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XRP6976F_3501

Identifier Type: -

Identifier Source: org_study_id