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Active, Not Recruiting

NCT Number: NCT03972930

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated radiotherapy

Radiation

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

Primary outcomes

  1. Proportion of Participants With 2-year Local Control

    Time frame: up to 2 years

    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.

Secondary outcomes

  1. Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site

    Time frame: up to 2 years

    2-year local control rates will be reported separately for primary sites vs. metastatic sites.

  2. Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site

    Time frame: up to 5 years

    5-year local control rates will be reported separately for primary sites vs. metastatic sites with exact 95% CI.

  3. Complete Response Rate

    Time frame: up to 5 years

    The complete response (CR) rate will be reported with an exact 95% CI.

  4. Progression Free Survival

    Time frame: up to 5 years

    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.

  5. Overall Survival

    Time frame: up to 5 years

    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.

  6. Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade

    Time frame: up to 8 weeks

    Unique toxicities tabulated by type and grade.

  7. Incidence of Long Term Toxicity

    Time frame: up to 5 years

    Tabulated by type and grade.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Jun 4, 2019
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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