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Clinical Trial NCT03972930 for Soft Tissue Sarcoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hypofractionated Radiotherapy for Soft Tissue Sarcomas Phase 2 48

Active, not recruiting
Clinical Trial NCT03972930 is designed to study Treatment for Soft Tissue Sarcoma. It is a Phase 2 interventional study that is active, not recruiting, having started on June 11, 2019, with plans to enroll 48 participants. Led by University of Wisconsin, Madison, it is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on January 17, 2025.
Brief Summary
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 ...Show More
Official Title

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Conditions
Soft Tissue Sarcoma
Other Study IDs
  • UW18149
  • 2019-0360 (Other Identifier) (Institutional Review Board)
  • A533300 (Other Identifier) (UW Madison)
  • SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Other Identifier) (UW Madison)
  • NCI-2019-03768 (Registry Identifier) (NCI Trial ID)
  • Protocol Version 5/5/2021 (Other Identifier) (UW Madison)
NCT ID Number
NCT03972930
Start Date (Actual)
2019-06-11
Last Update Posted
2025-01-17
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Hypofractionated Radiotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHypofractionated Radiotherapy for Soft Tissue Sarcoma
Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.
Hypofractionated Radiotherapy
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Proportion of Participants with 2-year Local Control
The primary endpoint is 2-year local control, defined as the proportion of participants whose best response as determined per RECIST criteria using imaging is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of all participants who have received at least one fraction. Local control will be reported with an exact 95% confidence interval (CI).
up to 2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 with exact 95% CI.
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.
up to 5 years
Complete Response Rate
The complete response (CR) rate will be reported with an exact 95% CI.
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.
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.
up to 5 years
Incidence of Acute Toxicity
Tabulated by type and grade.
up to 8 weeks
Incidence of Long Term Toxicity
Tabulated by type and grade.
up to 5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
  • Participant refuses surgery or is aware that surgery is not recommended for them
  • Karnofsky performance status > 60
  • Able to understand and sign an informed consent form

  • Pregnant
  • Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
  • Unable to undergo imaging or positioning necessary for radiotherapy planning
  • Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
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1 Study Locations in 1 Countries

Wisconsin

University of Wisconsin, Madison, Wisconsin, 53705, United States