Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
University of Wisconsin, Madison
Summary
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.
Description
Standard treatment for soft tissue sarcomas is a combination of radiation therapy and surgery. Radiation therapy is usually done prior to the surgical removal of the tumor. Most commonly, conventionally fractionated radiotherapy is used for soft tissue sarcomas, in which radiation therapy is given over 25 treatments in a time period of approximately 5 weeks. Conventionally fractionated radiotherapy is radiation treatment that is delivered over the course of several days; typically divided into doses that are delivered each weekday over a set number of weeks. Each radiation treatment is called…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck * No prior sarcoma-directed chemotherapy or radiotherapy * 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 consultin…
Interventions
- RadiationConventional Fractionated
50 Gy in 25 fractions will be prescribed to cover 95% of the planning tumor volume (PTV). More than 99% of the PTV should receive \> 97% of the prescribed dose. For dose homogeneity, no more than 20% of the PTV will receive ≥ 110% prescription dose.
- RadiationHypofractionated
27.5 Gy in 5 fractions will be prescribed to cover 95% of the PTV. More than 99% of the PTV should receive \> 97% of the prescribed dose
Location
- University of Wisconsin Hospital and ClinicsMadison, Wisconsin