Prospective trial to evaluate staged neck dissection or elective neck radiotherapy in patients with CT-staged T1-2 N0 squamous cell carcinoma of the oral tongue.

Background: A prospective study was undertaken to evaluate a policy of selective, single-modality elective neck treatment in T1-2, node-negative oral tongue squamous cell carcinoma.

Methods: Where the primary tumor showed 1 of the 4 key pathological criteria (greater than 7 mm of muscle invasion, less than 5 mm of resection margin, perineural or lymphovascular invasion), radiotherapy was delivered to the primary site and the at-risk undissected neck. Otherwise patients underwent ipsilateral neck dissection within 4 weeks of initial resection. Prospective quality of life assessments were performed.

Results: The study was closed after accrual of 25 patients, because the high locoregional recurrence rate met early stopping criteria. With a median follow-up of 3.4 years, the locoregional recurrence rate was 23%. The 4-year overall and disease-free survival rates were 71% and 64%, respectively.

Conclusion: The poor disease-free survival reflects the need for better prognostic markers and more aggressive treatment in these patients.