NCT01312493

Selective IMRT for Locally Advanced Head and Neck Carcinoma With Concurrent Panitumumab

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	Weekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments.
RADIATION	Intensity Modulated Radiation Therapy	The dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks.

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2011-03-10
• Last updated: 2015-08-28