Hypofractionated Radiotherapy for Soft Tissue Sarcomas

University of Wisconsin (UW)

Status and phase: Active, not recruiting; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Radiation: Hypofractionated Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03972930

A533300 (Other Identifier)

2019-0360 (Other Identifier)

SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Other Identifier)

UW18149

Protocol Version 5/5/2021 (Other Identifier)

NCI-2019-03768 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Experimental group

Description:

Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.

Treatment:

Radiation: Hypofractionated Radiotherapy