Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01312493
Status:
WITHDRAWN
Last Update Posted:
2015-08-28
First Post:
2011-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding source was terminated before enrollment of first subject
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-randomized phase II study of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous carcinoma of the head and neck.
Detailed Description:
This is a non-randomized phase II trial of targeted radiotherapy (RT) administered concurrently with panitumumab in patients with locally advanced squamous cell carcinoma of the head and neck. This protocol addresses patients with medical comorbidities that make them poor candidates for concurrent chemotherapy. Radiotherapy treatment will be directed at disease visible on diagnostic imaging modalities and the ipsilateral hemi-neck, sparing elective regions in the contralateral N0 hemi-neck with less than 20% chance of microscopic involvement. We explore the following hypothesis: Can acceptable locoregional disease control be obtained with less treatment-related morbidity by focusing RT on regions of gross disease, sparing regions with a low risk of harboring subclinical disease from elective RT?
Study Oversight
Has Oversight DMC:
True
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?: