Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial

作者：Thomas Held, Kristin Lang, Sebastian Regnery, Katharina Weusthof, Adriane Hommertgen, Cornelia Jäkel, Eric Tonndorf‐Martini, Johannes Krisam, Peter K. Plinkert, Karim Zaoui, Christian Freudlsperger, Julius Moratin, Jürgen Krauß, Semi Harrabi, Klaus Herfarth, Jürgen Debus, Sebastian Adeberg · 发表于：Radiation Oncology · 年份：2020 · DOI：10.1186/s13014-020-01625-0 · 被引用次数：16 · 研究领域：Head and Neck Cancer Studies、Radiation Therapy and Dosimetry、Advanced Radiotherapy Techniques

BACKGROUND: Intensity-modulated re-radiotherapy (reIMRT) has been established as a standard local treatment option in patients with non-resectable, recurrent head and neck cancer (rHNC). However, the clinical outcome is unfavorable and severe toxicities (≥grade III) occurred in 30-40% of patients. The primary aim of the current trial is to investigate carbon ion reirradiation (reCIRT) compared to reIMRT in patients with rHNC regarding safety/toxicity as well as local control, overall survival (OS), and quality of life (QoL). METHODS: The present trial will be performed as a single center, two-armed, prospective phase II study. A maximum of 72 patients will be treated with either reIMRT or reCIRT to evaluate severe (≥grade III) treatment-related toxicities (randomization ratio 1:1). The primary target value is to generate less than 35% acute/subacute severe toxicity (≥grade III), according to the Common Terminology Criteria for Adverse Events v5.0, within 6 months after study treatment. The total dose of reirradiation will range between 51 and 60 Gy or Gy (RBE), depending primarily on the radiotherapy interval and the cumulative dose to organs at risk. Individual dose prescription will be at the discretion of the treating radiation oncologist. The local and distant progression-free survival 12 months after reirradiation, the OS, and the QoL are the secondary endpoints of the trial. Explorative trial objectives are the longitudinal investigation of clinical patient-related para...