Phase 2 Trial of SBRT for Patients With Inoperable Head and Neck Cancer

Title: Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)¹

Principal Investigator: Jack Phan, MD, PhD, University of Texas MD Anderson Cancer Center

Description: For this phase 2, randomized trial (ClinicalTrials.gov Identifier: NCT03164460), researchers are evaluating whether stereotactic body radioablative therapy (SBRT) is superior to conventional radiation among patients with head and neck cancer.

All patients will have small, inoperable tumors that have been previously irradiated.

This study has 2 arms: the SBRT arm, in which patients will receive 45 Gy in 5 fractions over about 2 weeks, and the conventional radiation arm, in which patients will receive 66 to 70 Gy in 33 to 35 fractions over 6 to 7 weeks.

All patients will complete questionnaires at baseline, during treatment, and after treatment.

The primary outcome measure is toxicity. Secondary measures include local disease control, locoregional failure-free survival, and patient-reported outcomes.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03164460.

Status: This study is open and recruiting patients as of June 15, 2017.

This study is sponsored by the MD Anderson Cancer Center.

Reference

1. Clinicaltrials.gov. Reirradiation for small inoperable head and neck tumors. NCT03164460. https://clinicaltrials.gov/ct2/show/NCT03164460. Accessed June 15, 2017.