This phase II trial tests whether hypofractionated radiation therapy versus conventionally fractionated radiation therapy works better to shrink tumors before surgery in patients with soft tissue sarcoma. Conventionally fractionated radiotherapy is radiation treatment that is delivered over the course of a number of weeks; typically divided into doses that are delivered each weekday over a set number of weeks. Each radiation treatment is called a “dose fraction”, thus the name “fractionated”. Hypofractionated radiotherapy is a technique in which a higher dose of radiation is given over a fewer number of treatments. Giving hypofractionated radiation therapy may better to treat soft tissue sarcomas while minimizing side effects and minimizing the time between diagnosis and surgical resection compared to conventionally fractionated radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05109494.
Locations matching your search criteria
United States
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterStatus: Active
Contact: Zachary S. Morris
University of Wisconsin Carbone Cancer Center - University HospitalStatus: Active
Contact: Zachary S. Morris
PRIMARY OBJECTIVE:
I. Evaluate soft tissue sarcoma tumor response to neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
SECONDARY OBJECTIVES:
I. Evaluate soft tissue sarcoma tumor response to neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
II. Evaluate acute wound healing complications after neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
III. Evaluate late toxicity in patients undergoing neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
IV. Evaluate local tumor control and progression-free survival after hypofractionated versus conventionally fractionated radiotherapy.
EXPLORATORY OBJECTIVES:
I. Evaluate surgically resected tissue for markers of tumor cell susceptibility to immune response, immune infiltration, and anti-tumor immune response following neoadjuvant hypofractionated compared to conventionally fractionated radiotherapy.
II. To evaluate quality of life in patients undergoing neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo hypofractionated radiation therapy over 30-60 minutes for 5 treatments over up to 3 weeks. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and follow-up.
ARM II: Patients undergo conventionally fractionated radiation therapy over 30-60 minutes for 25 treatments over up to 7 weeks. Patients also undergo CT or MRI during screening and follow-up.
After completion of study treatment, patients are followed up every 3-6 months for 2-3 years, then every 6-12 months for a total of 5 years.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorZachary S. Morris
