Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab
|ClinicalTrials.gov Identifier: NCT01312493|
Recruitment Status : Withdrawn (Funding source was terminated before enrollment of first subject)
First Posted : March 10, 2011
Last Update Posted : August 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Panitumumab Radiation: Intensity Modulated Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
- Recurrence Rate of Locally Advanced Head & Neck Cancer [ Time Frame: 2 Years ]Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
- Patterns of Failure [ Time Frame: 2 Years ]Evaluate locoregional recurrences to see if they arise in regions that were spared vs. treated, and assess long-term control after salvage therapy.
- Time to Relapse [ Time Frame: first day of therapy to the first sign of progressive disease ]Imaging for recurrence via CT scan will occur at 8 weeks (+/-5 days) post-RT, and will be repeated at 6, 9, 12, and 24 months from start of treatment.
- Morbidity of Treatment [ Time Frame: From screening until 30 days after treatment ]Toxicity will be assessed according to the NCI CTCAE v4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312493
|Principal Investigator:||Neil Hayes, MD||University of North Carolina, Chapel Hill|