Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer (TopROC)

Background:

For loco-regionally advanced, but transorally resectable oropharyngeal cancer (OPSCC), the current standard of care includes surgical resection and risk-adapted adjuvant (chemo)radiotherapy, or definite chemoradiotherapy with or without salvage surgery. To date, the different therapeutic approaches to transorally resectable oropharyngeal cancer have not been directly compared to each other in a randomized trial yet. The goal of this study is to compare initial transoral surgery with definitive chemoradiation for resectable OPSCC, especially with regards to local and regional control.

Methods:

TopROC is a prospective, two-arm, open label, randomized, multicenter, controlled comparative effectiveness trial designed to assess the difference in treatment-related outcome in patients with OPSCC. Patients with locally advanced but transorally resectable OPSCC will be randomly assigned to surgical treatment (Arm A) or radiotherapy (Arm B). Standard of care treatments will be performed according daily routine practice. Arm A consists of transoral surgical resection with neck dissection followed by risk-adapted adjuvant (chemo)radiation. Patients treated in Arm B receive standard chemoradiation, residual tumor may be subject to salvage surgery. Primary endpoint is time to local or locoregional failure or death from any cause (LRF). 280 patients will be included in approximately 20 centers in Germany. This trial is supported by the German Cancer Aid and accompanied by a large scientific support program. Recruitment started in January 2018. Clinical trial information: NCT03691441

Publication History

Publication Date:
23 April 2019 (online)