Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502463
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2007-07-15
Brief Title:
Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage IIIIV - a Methodical Trial
Sponsor:
Austrian South Oncology Group
Organization:
Austrian South Oncology Group
Study Overview
Official Title:
Induction by DocetaxelCisplatin5-Fluorouracil TCF Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
Status:
COMPLETED
Status Verified Date:
2024-02
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:
ASOG-HNO1
Brief Summary:
The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage IIIIV
Detailed Description:
3 Cycles of Docetaxel 75 mgm2 on d1 Cisplatin 75 mgm2 on d1 5-FU 750 mgm2 on days 1-5 as continuous iv infusion Duration of 1 cycle 21 days
Followed by Cetuximab 400 mgm2 Start of radiotherapy 1 week after the first application of Cetuximab During radiotherapy 35 x 2 Gy Cetuximab 250 mgm2 weekly Up to 8 applications of Cetuximab
Followed by Cetuximab 400 mgm2 Start of radiotherapy 1 week after the first application of Cetuximab During radiotherapy 35 x 2 Gy Cetuximab 250 mgm2 weekly Up to 8 applications of Cetuximab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None