Canadian Cancer Trials Group Bulletins

General


Highlighted Trial -- HN.6

A Phase III Study of Standard Fractionation Radiotherapy with Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy with Panitumumab in Patients with Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck (Canadian Cancer Trials Group HN.6)
Study Chairs Drs John Waldron and Lillian Siu

This innovative, national phase III study was activated on December 18, 2008 and compares the relative efficacy of a chemotherapy-sparing regimen of accelerated fractionation radiotherapy plus the EGFR antibody panitumumab to standard cisplatin-based chemoradiotherapy in patients with locally-advanced tumours of the head and neck. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, local progression-free survival, regional progression-free survival, distant metastasis, and adverse events. In addition to addressing the issue of tumour control, this study will prospectively evaluate the impact of therapy on quality of life and swallowing-related quality of life. Other planned correlative science studies included in this protocol are economic evaluation (healthcare utilization, health utilities and indirect costs) and correlation of molecular markers in biological specimens with outcome.

The enthusiasm and interest expressed by Canadian head and neck oncologists for this study has been outstanding. Eight patients have been randomized by Princess Margaret Hospital to date, and the local activation process in ongoing in several centres.

If centres are interested in participating in this trial, they should contact Alexander Montenegro, Study Coordinator for HN.6. Trial-specific information, including the protocol, sample consent, and other local activation documentation can be found on the HN.6 website at http://www.ctg.queensu.ca/trials/head_neck/hn6/hn6.html.