[Efficacy of postoperative radiation therapy for squamous cell carcinoma of the head and neck: results of a prospective randomised clinical trial].
INTRODUCTION: A prospective randomised clinical trial was designed to assess the usefulness of postoperative radiotherapy (RT) in terms of loco-regional control and survival in patients with surgically treated advanced (stages III to IV) head and neck squamous cell carcinoma with negative margins and without extracapsular extension in positive neck nodes. MATERIALS AND METHODS: Between 1994 and 1995, 51 patients were included in the study and 42 were considered evaluables (from which 21 received postoperative RT). A minimum follow-up of 3 years was required. RESULTS: The loco-regional recurrence rates were identical in irradiated and non-irradiated patients (15/21 cases--70%--in each group), as was the 5-year disease-specific survival (35% for both groups). The only parameter that was associated with a reduced disease-specific survival was the presence of regional lymph node metastases. CONCLUSION: Our results suggest that postoperative RT does not increase loco-regional control or survival in patients with completely resected advanced head and neck squamous cell carcinoma.