Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273546
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2006-01-06
Brief Title:
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
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Phase III Multicenter Trial of Neoadjuvant Docetaxel Taxotere Plus Cisplatin and 5-Fluorouracil TPF Versus Neoadjuvant Cisplatin Plus 5-Fluorouracil Followed by Concomitant Chemoradiotherapy to Improve the Overall Survival and Progression Free Survival in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1To 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
2The 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 CRPR toxicity and to evaluate the relationship of tumor markers and response to therapy
2The 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 CRPR toxicity and to evaluate the relationship of tumor markers and response to therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RP-56976-V-324 | None | None | None |