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NCT00401323 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
568
Enrollment target

NCT00401323: Completed Phase 2 study, sponsored by Sanofi.

NCT00401323 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 568 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (327% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00401323, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
568 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG cisplatin
  • DRUG 5-fluorouracil (5-FU)
  • DRUG docetaxel (XRP6976)

Trial Details

FieldValue
Enrollment Target 568 participants
Start Date 1998-01
Est. Completion 2003-06
Phase Phase 2
Sanofi

713 total trials

What the finished NCT00401323 record still lists

NCT00401323 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (327% higher).

The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.

NCT00401323 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00401323 about?

NCT00401323 is a clinical study titled "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.

What is the current status of trial NCT00401323?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 568 participants. The study started on 1998-01. Estimated completion is 2003-06.

What interventions are being tested in trial NCT00401323?

The interventions under investigation include: cisplatin (DRUG), 5-fluorouracil (5-FU) (DRUG), docetaxel (XRP6976) (DRUG).

Who is sponsoring clinical trial NCT00401323?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00401323's enrollment target sits among peer trials

568 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00401323, the US trial registry maintained by the National Library of Medicine. NCT00401323 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.