Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508664
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2007-07-27
Brief Title:
Docetaxel Cisplatin TP Radiation - Cetuximab in Larynx Carcinoma CA
Sponsor:
ClinAssess
Organization:
University of Leipzig
Study Overview
Official Title:
Randomised Phase II Screening Study to be Used in an TPTPF-chemotherapy Short Induction Before TPTPF-induction Radiotherapy With or Without Cetuximab in the Primary Therapy of the Only by Laryngectomy Operable Carcinoma of the LarynxHypopharynx
Status:
COMPLETED
Status Verified Date:
2015-06
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:
DeLOS II
Brief Summary:
The DeLOS II trial is a multicenter randomised phase II trial investigating a TP5-Fluorouracil TPF-chemotherapy with or without cetuximab for Patients with only by laryngectomy operable carcinoma of the larynxhypopharynx Patients were divided in responder or non-responder after 4 weeks Since August 2009 Responder receive TP with or without Cetuximab radiation Until february 2009 Responder received TPF with or without Cetuximab radiation Planned accrual is 85 patients per treatment arm The primary study endpoint is a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomisation
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