Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345084
Status:
WITHDRAWN
Last Update Posted:
2015-07-27
First Post:
2011-04-28
Brief Title:
Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen With or Without Nimotuzumab in Unresectable Locally Advanced Epidermoid Carcinoma of the Head and Neck
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
change company strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICAP
Brief Summary:
Primary to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause in both treatment groups
Secondary to compare the progression-free survival incidence of locoregional failure site of the first recurrenceprogression objective response rate assessment quality of life assessment and incidence of adverse events
Secondary to compare the progression-free survival incidence of locoregional failure site of the first recurrenceprogression objective response rate assessment quality of life assessment and incidence of adverse events
Detailed Description:
This is a phase III superiority national open-label randomized and two-arm study
Patients enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months
All patients taking part in the study must sign an informed consent The patients will have stage III or IV unresectable head and neck SCC performance status 0 or 1
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage 11
Patients enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months
All patients taking part in the study must sign an informed consent The patients will have stage III or IV unresectable head and neck SCC performance status 0 or 1
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage 11
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