Locally/Regionally recurrent squamous cancers of the head and neck following radiotherapy are often not amenable to surgical salvage. Conventionally fractionated re-irradiation has been investigated, but survivals are poor. Stereotactic radiotherapy (SBRT) has been proposed as an alternative to conventionally fractionated re-irradiation, but reports to date have not shown significantly improved outcomes. Cisplatin has been shown to sensitize squamous carcinomas to radiotherapy even at doses > 2 Gy. We therefore designed a phase I dose escalation study of SBRT for re-irradiation with concurrent cisplatin (MCC 17799, ClinicalTrials.gov: NCT02158234).
This is a phase I, open label, dose escalation safety and tolerability study of SBRT in combination with cisplatin in patients with locally or regionally recurrent squamous cell carcinoma of the head and neck with prior radiotherapy > 45 Gy. Cohort 1 will receive 30 Gy SBRT given every other day for 5 fractions with cisplatin at 15 mg/m2 prior to each fraction. Dose escalation of SBRT to 35 or 40 Gy may occur based on evaluation of dose limiting toxicities up to 90 days following therapy. Approximately 21 patients will be enrolled at our institution. The primary endpoint is to define the maximum tolerated dose of SBRT with concurrent cisplatin. Secondary endpoints include loco-regional control, overall survival, and adverse events.
Clinical trial identification
MCC 17799; ClinicalTrials.gov NCT02158234
Legal entity responsible for the study
Department of Radiation Oncology, Moffitt Cancer Center
All authors have declared no conflicts of interest.