Title: A Phase I Dose Escalation Trial of Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of the Head and Neck1

Principal Investigator(s): Jimmy Caudell, MD, PhD, H. Lee Moffitt Cancer Center and Research Institute

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Description: For this single arm, open label, dose escalation, phase 1 study (ClinicalTrials.gov Identifier: NCT02158234), researchers are evaluating the maximum tolerated dose and efficacy of stereotactic body radiation therapy (SBRT) with cisplatin among patients with recurrent or unresectable squamous cell carcinoma of the head and neck.

The starting dose will be 6 Gy for 5 fractions. Prior to each SBRT fraction, patients will receive 15 mg/m2 of cisplatin.

The primary outcome is maximal tolerated dose; the secondary outcomes are local control rate and overall survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02158234.

Status: This study is open and recruiting patients as of May 1, 2017.

This study is sponsored by the H. Lee Moffitt Cancer Center and Research Institute.


  1. Clinicaltrials.gov. Stereotactic body radiotherapy and concurrent cisplatin for re-irradiation of unresectable, recurrent squamous cell carcinomas of head and neck. NCT02158234. https://clinicaltrials.gov/ct2/show/NCT02158234. Accessed May 1, 2017.