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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
University of Wisconsin
Madison, Wisconsin, United States
Proportion of Participants With 2-year Local Control
The primary endpoint is 2-year local control, defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, Progressive Disease (PD), at least a 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient change for PR, PD, or CR.
Time frame: up to 2 years
Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site
2-year local control rates will be reported separately for primary sites vs. metastatic sites.
Time frame: up to 2 years
Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site
5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.
Time frame: up to 5 years
Complete Response Rate
The complete response (CR) rate will be reported with an exact 95% CI.
Time frame: up to 5 years
Progression Free Survival
Progression free survival (PFS) defined with follow-up radiological assessment with PFS calculated from the point of start of hypofractionated radiotherapy to the point of recurrence or death. Participants without documented progression who are alive at last follow-up will be censored at the date of the last radiologic assessment. PFS will be estimated using the Kaplan-Meier method.
Time frame: up to 5 years
Overall Survival
Overall survival (OS) defined from the point of start of hypofractionated radiotherapy to the time of death or last follow-up if alive. Participants who are alive at last follow-up will be censored. OS will be estimated using the Kaplan-Meier method.
Time frame: up to 5 years
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade
Unique toxicities tabulated by type and grade.
Time frame: up to 8 weeks
Incidence of Long Term Toxicity
Tabulated by type and grade.
Time frame: up to 5 years
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