This clinical trial tests how well 5-day hypofractionated radiotherapy (HFRT) delivered before surgery (preoperative) works in treating patients with soft tissue sarcoma. The current standard approach to the management of soft tissue sarcoma is a combination of radiotherapy and surgery. Current guidelines recommend preoperative conventional fractionated radiotherapy (CFRT), which involves 5-6 weeks of daily treatments. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Undergoing HFRT before surgery may make the tumor smaller, allowing for a more complete surgical resection. Preoperative HFRT can shorten the duration of treatment and may be a safe and effective way of treating soft tissue sarcoma in patients undergoing surgical resection.
Additional locations may be listed on ClinicalTrials.gov for NCT05776667.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the feasibility of preoperative 5-day HFRT.
SECONDARY OBJECTIVE:
I. To evaluate incidence of favorable pathologic response, incidence of major wound complications, local control, acute and 1-year late toxicity of preoperative 5-day HFRT.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To compare the socio-demographic profiles of trial participants with those of soft tissue sarcoma (STS) patients who would have met trial eligibility criteria and were treated with CFRT at Hollings Cancer Center (HCC) in the 3 years prior to study opening.
II. To compare the retention rate for radiotherapy at HCC in patients meeting trial eligibility criteria during the prior 3 years with the retention rate for radiotherapy during the study period.
III. To compare serum levels of SFRP2 before and after preoperative 5-day HFRT.
IV. To evaluate the association between changes in serum levels of SFPR2 and pathologic response to preoperative 5-day HFRT.
V. To evaluate patient satisfaction with the decision to participate in a clinical trial of preoperative 5-day HFRT.
VI. To assess the importance of the shorter duration of radiotherapy in an individual patient’s decision to participate in the study.
OUTLINE:
Patients undergo preoperative HFRT for 5 fractions once daily over 5 consecutive weekdays followed by standard of care surgical resection on study. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.
After completion of study intervention, patients are followed up at 2 weeks and 3, 6, 9, and 12 months post-operatively.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMedical University of South Carolina
Principal InvestigatorJennifer L. Harper
