In the phase 2 trial HYPORT-STS conducted at MD Anderson Cancer Center, moderately hypofractionated preoperative radiotherapy to patients with soft tissue sarcoma was found to be effective with a favorable safety profile.

In this single arm trial, 120 eligible patients, most had sarcoma of the lower extremity (65%), were treated with preoperative radiotherapy at a total dose of 42.75 Gy in 15 fractions of 2.85 Gy per day over the course of 3 weeks. The trial’s primary end point was major wound complication within 120 days of surgery, secondary end points included local recurrence-free survival, time to local relapse, acute radiation toxicity, and late radiation toxicity.

After median follow-up of 24 months, 37 patients developed a major wound complication at a median time of 37 days after surgery. No patient had acute radiation toxicity (during radiotherapy or within 4 weeks of the radiotherapy end date) of grade 3 or worse or an on-treatment serious adverse event. Only four patients had late radiation toxicity (≥6 months post-surgery) of at least grade 3. Moreover, In a population of 119 patients who were evaluated for local control, 5% were found to have locally relapsed at a median follow-up of 16 months. Therefore, this regimen could be a more convenient alternative to conventionally fractionated radiotherapy.