Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 26, 2007

Primary Completion Date

May 21, 2014

Study Completion Date

July 26, 2018

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Cetuximab

Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.

DEVICE

Stereotactic radiosurgery

Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)

Trial Locations (1)

15232

University of Pittsburgh Cancer Institute, Pittsburgh

All Listed Sponsors
lead

David A. Clump, MD, PhD

OTHER

NCT01104922 - Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter | Biotech Hunter