Hypofractionated Radiotherapy for Soft Tissue Sarcomas

NCT03972930 | Active Not Recruiting Phase 2 DMC FDA Device

• 6 other identifiers: UW181492019-0360A533300SMPH/HUMAN ONCOLOGY/HUMAN ONCONCI-2019-03768Protocol Version 5/5/2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Soft Tissue Sarcoma

Keywords

Hypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Participants with 2-year Local Control: Primary Site vs Metastatic Site

  up to 2 years

• Proportion of Participants with 5-year Local Control: Primary Site vs Metastatic Site

  up to 5 years

• Complete Response Rate

  up to 5 years

• Progression Free Survival

  up to 5 years

• Overall Survival

  up to 5 years

Study Arms (1)

Hypofractionated Radiotherapy for Soft Tissue Sarcoma

EXPERIMENTAL

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

Interventions

Hypofractionated Radiotherapy RADIATION

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

Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Sarcoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Zachary Morris, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: June 11, 2019
• Primary Completion: November 28, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)