A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence
Currently, postoperative chemoradiation is recommended for head and neck squamous cell
carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic
lymph node, or positive resection margin. Other patients may receive postoperative
radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or
more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior
to patients who had minor risk factors less than 3. Thus, we believe that current
postoperative radiotherapy is insufficient for patients with multiple minor risks. A
clinical trial should be raised to help these patients. However, the patient number of this
group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of
postoperative chemoradiation to test and prospectively observe the treatment outcome.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Any kind of cancer recurrence, measured by physical examination or image study. Pathologic confirmation is recommended.
Kang-Hsing Fan, MD
Chang Gung Memorial Hospital - LinKou Branch
Taiwan: Department of Health