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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 500 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 1999-05 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00273546
The ClinicalTrials.gov registry entry for NCT00273546 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XRP6976 (Docetaxel/Taxotere) is the first listed.
NCT00273546 reports 0 study locations.
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.
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