Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

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 Overview

• Status: Active, not recruiting
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Radiation: Hypofractionated Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated 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.	Radiation: Hypofractionated Radiotherapy; Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Zachary Morris, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypofractionated Radiotherapy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No