Title
Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas

Description
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.

Objective
Evaluate soft tissue sarcoma tumor response to neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
Evaluate acute wound healing complications after neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
Evaluate late toxicity in patients undergoing neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
Evaluate local tumor control and progression-free survival after hypofractionated versus conventionally fractionated radiotherapy

Treatment Active Comparator: Conventional Fractionated
radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Experimental: Hypofractionated
the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT

Key Eligibility Inclusion Criteria:

Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck

No prior sarcoma-directed therapy

Age > 18 years

Karnofsky performance status > 60

Able to understand and sign an informed consent

Life expectancy of greater than 12 weeks

Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion

Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)

Adequate bone marrow function as defined by absolute neutrophil count > 500/mcL, hemoglobin > 8 g/dL, platelets > 50,000/mcL; adequate renal function as defined by creatinine clearance > 30 mL/min

Pregnant

Unable to undergo imaging or positioning necessary for radiotherapy planning

Applicable Disease Sites
Sarcoma

Participating Institutions
Johnson Creek, UW Cancer Center; UW Health Eastpark Medical Center; UW Health University Hospital