Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
NCT ID: NCT05109494
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2022-04-06
2028-11-30
Brief Summary
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Detailed Description
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Conventionally fractionated radiotherapy is radiation treatment that is delivered over the course of several days; typically divided into doses that are delivered each weekday over a set number of weeks. Each radiation treatment is called a "dose fraction", thus the name "fractionated".
Hypofractionated radiotherapy is a technique in which a higher dose of radiation is given over a fewer number of treatments. Early studies have suggested that hypofractionated radiotherapy will be safe and effective for pre-operative treatment of soft tissue sarcomas. However, because this disease is rare, there are different kinds of soft tissue sarcomas, these tumors can occur anywhere in the body, and conventionally fractionated radiotherapy remains standard, more study is needed to find out if hypofractionated radiotherapy is a safe and effective treatment for this disease.
Therefore, the investigators plan to compare patients treated with conventionally fractionated radiotherapy over 25 treatments in a time period of 5 weeks to patients treated with hypofractionated radiotherapy over 5 treatments in a time period of 1-2 weeks.
The investigators hypothesize hypofractionated radiotherapy in the pre-operative treatment of soft tissue sarcomas can effectively treat soft tissue sarcomas while minimizing side effects and minimizing the time between diagnosis and surgical resection.
Patients with liposarcoma (LPS) or undifferentiated pleomorphic sarcoma (UPS) may receive standard of care pembrolizumab concurrently with radiation therapy at the discretion of their treating medical oncologist.
Primary Objective
* Evaluate soft tissue sarcoma tumor response to neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
Secondary Objectives
* Evaluate soft tissue sarcoma tumor response to neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
* Evaluate acute wound healing complications after neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
* Evaluate late toxicity in patients undergoing neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
* Evaluate local tumor control and progression-free survival after hypofractionated versus conventionally fractionated radiotherapy.
Exploratory Objectives
* Evaluate surgically resected tissue for markers of tumor cell susceptibility to immune response, immune infiltration, and anti-tumor immune response following neoadjuvant hypofractionated compared to conventionally fractionated radiotherapy
* Evaluate quality of life in patients undergoing neoadjuvant hypofractionated versus conventionally fractionated radiotherapy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Fractionated
radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Conventional Fractionated
50 Gy in 25 fractions will be prescribed to cover 95% of the planning tumor volume (PTV). More than 99% of the PTV should receive \> 97% of the prescribed dose. For dose homogeneity, no more than 20% of the PTV will receive ≥ 110% prescription dose.
Hypofractionated
the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Hypofractionated
27.5 Gy in 5 fractions will be prescribed to cover 95% of the PTV. More than 99% of the PTV should receive \> 97% of the prescribed dose
Interventions
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Conventional Fractionated
50 Gy in 25 fractions will be prescribed to cover 95% of the planning tumor volume (PTV). More than 99% of the PTV should receive \> 97% of the prescribed dose. For dose homogeneity, no more than 20% of the PTV will receive ≥ 110% prescription dose.
Hypofractionated
27.5 Gy in 5 fractions will be prescribed to cover 95% of the PTV. More than 99% of the PTV should receive \> 97% of the prescribed dose
Eligibility Criteria
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Inclusion Criteria
* No prior sarcoma-directed chemotherapy or radiotherapy
* Age ≥ 18 years
* Karnofsky performance status ≥ 60
* Able to understand and sign an informed consent
* Life expectancy of greater than 12 weeks
* Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion
* Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)
* Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min
Exclusion Criteria
* Unable to undergo imaging or positioning necessary for radiotherapy planning
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Zachary Morris, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Locations
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Cancer Connect
Role: primary
Other Identifiers
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Protocol Version 11/21/2024
Identifier Type: OTHER
Identifier Source: secondary_id
A533300
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-11388
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0957
Identifier Type: OTHER
Identifier Source: secondary_id
UW21049
Identifier Type: -
Identifier Source: org_study_id