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Overview

Status Active not recruiting
Phase Phase 2
Sponsor University of Wisconsin, Madison
Start date June 2019
End date December 2024
Enrollment 48 participants
Identifiers NCT03972930, UW18149, 2019-0360, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, NCI-2019-03768, Protocol Version 5/5/2021

Conditions

Soft Tissue Sarcoma

Treatments

Hypofractionated Radiotherapy

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.

Locations

University of Wisconsin
Madison, Wisconsin

Inclusion Criteria

» Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
» Participant refuses surgery or is aware that surgery is not recommended for them
» Karnofsky performance status > 60
» Able to understand and sign an informed consent form

Exclusion Criteria

» Pregnant
» Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
» Unable to undergo imaging or positioning necessary for radiotherapy planning
» Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.