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
- To compare the progression-free survival (PFS) of patients with locally advanced
squamous cell carcinoma of the head and neck treated with standard fractionation
radiotherapy and high-dose cisplatin vs accelerated fractionation radiotherapy and
- To compare overall survival of patients treated with these regimens.
- To compare local and regional PFS of patients treated with these regimens.
- To compare distant metastasis in patients treated with these regimens.
- To compare adverse events, including late radiotherapy-related adverse events in
patients treated with these regimens.
- To compare quality of life (QOL) of patients treated with these regimens.
- To compare swallowing-related QOL of patients treated with these regimens.
- To compare economic evaluation (cost effectiveness analysis and cost utility),
including both healthcare utilization and indirect costs.
OUTLINE: This is a multicenter study. Patients are stratified according to T category (T1-3
vs T4), nodal status (N0-1 vs N2 vs N3), radiotherapy delivery modality (intensity-modulated
[IMRT] vs 3-D conformal [3D CRT]), anatomic location (hypopharynx vs oral cavity vs
oropharynx vs larynx), and participation in the optional swallowing impairment substudy (yes
vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once
daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1,
22, and 43 of radiotherapy.
- Arm II: Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once
or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90
minutes 1 week prior to and on days 15 and 36 of radiotherapy.
Treatment in both arms continues in the absence of disease progression or unacceptable
Quality of life (QOL) (FACT-H&N), swallowing-related QOL (MDADI, SWAL-QOL), swallowing
function (FOIS), and economic evaluations (Lost Productivity questionnaire) are assessed
periodically during the study.
After completion of study treatment, patients are followed periodically for at least 5
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
Lillian L. Siu, MD, FRCPC
Princess Margaret Hospital, Canada
Canada: Health Canada