Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Soft Tissue Sarcoma Clinical Trial

Official title:

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03972930
• Other study ID #: UW18149
• Secondary ID: 2019-0360A533300
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 11, 2019
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• Hypofractionated Radiotherapy
Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Complete Response Rate	The complete response (CR) rate will be reported with an exact 95% CI.	up to 5 years
Secondary	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
Secondary	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
Secondary	Incidence of Acute Toxicity	Tabulated by type and grade.	up to 8 weeks
Secondary	Incidence of Long Term Toxicity	Tabulated by type and grade.	up to 5 years

External Links

•   University of Wisconsin Carbone Cancer Center