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OpenTrials
Completed

NCT Number: NCT00401323

Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

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Key information

Conditions

Head and Neck Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sanofi-Aventis, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.

Treatment and study plan

docetaxel (XRP6976)

Drug

Other names: Taxotere

Cisplatin

Drug

5-fluorouracil (5-FU)

Drug

Primary outcomes

  1. time to progression

    Time frame: up to 5 years

Secondary outcomes

  1. overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Important dates

Study start
1998
Primary completion
2003
Study completion
2003
First posted
Nov 20, 2006
Registry last updated
Jan 20, 2011

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.

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