Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261703
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-12-02
Brief Title:
Docetaxel in Head and Neck Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin5-fluorouracil PF or DocetaxelCisplatin5-fluorouracil TPF Plus Chemoradiotherapy CRT Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer LAHNC
Status:
COMPLETED
Status Verified Date:
2012-05
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:
Primary Objective
Phase II To determine the best treatment scheme TPF vs PF
Phase III To compare the time to progression and the treatment failure at the 3 arms
Secondary objectives
To evaluate the safety at the 3 arms
To compare the progression overall survival and locoregional control at the 3 arms
Phase II To determine the best treatment scheme TPF vs PF
Phase III To compare the time to progression and the treatment failure at the 3 arms
Secondary objectives
To evaluate the safety at the 3 arms
To compare the progression overall survival and locoregional control at the 3 arms
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