NCT03972930

Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation. Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiotherapy	Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.

Timeline

• Start date: 2019-06-11
• Primary completion: 2024-11-28
• Completion: 2027-12-01
• First posted: 2019-06-04
• Last updated: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study