1. Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial
- Author
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Julius Moratin, Sebastian Adeberg, Semi Harrabi, Eric Tonndorf-Martini, Kristin Lang, Peter K. Plinkert, Jürgen Krauss, Cornelia Jäkel, Sebastian Regnery, Jürgen Debus, Johannes Krisam, Thomas Held, Karim Zaoui, Adriane Hommertgen, Klaus Herfarth, Katharina Weusthof, and Christian Freudlsperger
- Subjects
Male ,Organs at Risk ,medicine.medical_treatment ,Phases of clinical research ,030218 nuclear medicine & medical imaging ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,law ,Squamous cell carcinoma ,Prospective Studies ,Head and neck cancer ,Radiation oncologist ,Reirradiation ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,Cumulative dose ,Radiotherapy Dosage ,Common Terminology Criteria for Adverse Events ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Prognosis ,Oncology ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,Female ,Radiology ,lcsh:Medical physics. Medical radiology. Nuclear medicine ,Adult ,medicine.medical_specialty ,Adolescent ,Intensity-modulated radiotherapy ,lcsh:R895-920 ,Particle therapy ,Heavy Ion Radiotherapy ,lcsh:RC254-282 ,Heavy ions ,Young Adult ,03 medical and health sciences ,Clinical Trials, Phase II as Topic ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Aged ,Toxicity ,Squamous Cell Carcinoma of Head and Neck ,business.industry ,Radiotherapy Planning, Computer-Assisted ,Retrospective cohort study ,medicine.disease ,Radiation therapy ,Local control ,Radiotherapy, Intensity-Modulated ,Neoplasm Recurrence, Local ,business - Abstract
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 parameters, tumor parameters on radiological imaging, and blood-based tumor analytics. Discussion Recent retrospective studies suggested that reCIRT could represent a feasible and effective treatment modality for rHNC. This current randomized prospective trial is the first to investigate the toxicity and clinical outcome of reCIRT compared to reIMRT in patients with rHNC. Trial registration ClinicalTrials.gov; NCT04185974; December 4th 2019.
- Published
- 2020