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NCT00273546 · ClinicalTrials.gov registry record · Phase 3

Induction Chemotherapy Comparing Taxotere® Cisplatin and 5-Fluorouracil (TPF) With Standard Cisplatin and 5-Fluorouracil (PF) Followed by Chemoradiation in Locally Advanced Head and Neck Cancer

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
500
Enrollment target

NCT00273546: Completed Phase 3 study, sponsored by Sanofi.

NCT00273546 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00273546, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
500 participants
Enrollment target

Study Summary

* 1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by chemoradiotherapy in patients with locally advanced SCCHN. * 2.The main secondary endpoint is progression free survival (PFS). The other secondary endpoints are to evaluate and compare improvement of local symptoms; time-to-treatment failure; quality of life; clinical complete response rate (CR and CR/PR); toxicity and to evaluate the relationship of tumor markers and response to therapy.

Interventions

  • DRUG XRP6976 (Docetaxel/Taxotere)

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 1999-05
Est. Completion 2006-02
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00273546 record still lists

NCT00273546 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 1 intervention - of which XRP6976 (Docetaxel/Taxotere) is the first listed.

NCT00273546 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00273546 about?

NCT00273546 is a clinical study titled "Induction Chemotherapy Comparing Taxotere® Cisplatin and 5-Fluorouracil (TPF) With Standard Cisplatin and 5-Fluorouracil (PF) Followed by Chemoradiation in Locally Advanced Head and Neck Cancer". * 1.To compare overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5FU) or the control treatment (PF: cisplatin plus 5-FU) followed by chemoradiotherapy in patients with locally advanced SCCHN. * 2.The main secondary endpoint is progression free survival (PF...

What is the current status of trial NCT00273546?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 1999-05. Estimated completion is 2006-02.

What interventions are being tested in trial NCT00273546?

The interventions under investigation include: XRP6976 (Docetaxel/Taxotere) (DRUG).

Who is sponsoring clinical trial NCT00273546?

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

How this trial's enrollment target compares

Where NCT00273546's enrollment target sits among peer trials

500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00273546, the US trial registry maintained by the National Library of Medicine. NCT00273546 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.