Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00261703
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel in Head and Neck Cancer
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: