Soft Tissue SarcomaPhase 2NCT05109494
Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
A Phase 2 study testing Conventional Fractionated and Hypofractionated in people with Soft Tissue Sarcoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Conventional Fractionated and Hypofractionated
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to Nov 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
- 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
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- 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
Who cannot join
- Pregnant
- Unable to undergo imaging or positioning necessary for radiotherapy planning
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
About this study
Official title: Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
Read the detailed description
Standard treatment for soft tissue sarcomas is a combination of radiation therapy and surgery. Radiation therapy is usually done prior to the surgical removal of the tumor. Most commonly, conventionally fractionated radiotherapy is used for soft tissue sarcomas, in which radiation therapy is given over 25 treatments in a time period of approximately 5 weeks.
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
- Soft Tissue Sarcoma
- Being tested
- Conventional Fractionated, Hypofractionated
- Keywords
- hypofractionated, radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional FractionatedRadiation
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.
HypofractionatedRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional Fractionated | Active comparator | 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 Receives: Radiation: Conventional Fractionated |
| Hypofractionated | Experimental | 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 Receives: Radiation: Hypofractionated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Necrosis Score on Surgical Pathology Report
scores range from 0 to 2, lower scores mean there was less dying tissue present
Measured: up to 12 weeks from randomization
Secondary outcomes (6)
Incidence of Surgical Margin Status R0, R1, and R2
Pathology will determine the residual disease status on surgically resected tumor margin and classify it as R0 for no microscopic residual disease; R1 for microscopic residual disease; and R2 for gross residual disease. Incidence of margin status on the Surgical Pathology Report will be reported.
Measured: up to 12 weeks from randomization
Incidence of acute wound healing complications up to 120 days after surgery
Requiring one of the following:
- An unplanned secondary operation for wound repair, including debridement operative drainage, secondary wound closure including rotationplasty, free flaps, or skin grafts
- An invasive procedure, such as aspiration of seroma
- Readmission for wound care such as IV antibiotics
- Persistent deep packing for 120 days or longer
Measured: up to 6 months from randomization (up to 120 days after surgery)
Incidence of secondary operation for wound repair
Secondary operation defined as occurring under general or regional anesthesia with a purpose of wound repair or wound management after surgical resection
Measured: up to 6 months from randomization (up to 120 days after surgery)
Incidence of Late Toxicity
- Lymphedema, fibrosis, and joint stiffness resulting from RT are to be documented at all standard of care follow-up visits
- Toxicities will be graded according to CTCAE v 5.0
- Specifically, the presence of grade > 2 late toxicity, including lymphedema, fibrosis, and joint stiffness at 2 years +/- 3 months from randomization will be collected for all participants
Measured: up to 2 years plus or minus 3 months
Progression Free Survival (PFS)
PFS defined from randomization to the point of recurrence or death. Follow-up radiological assessment and biopsy when indicated.
Measured: up to 5 years
Rate of Local Tumor Recurrence
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start6 Apr 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized by the University of Wisconsin clinical trials team to conventional versus hypofractionated RT. Randomization will be blocked to maintain balance over time, with blocks randomly assigned to sizes of 4 or 6. The randomization will take into account receipt of immunotherapy, to allow for a balance of patients in both arms.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary Morris, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109494
- Sponsor's protocol ID
- 2021-0957
- Other IDs
- Protocol Version 11/21/2024, A533300, NCI-2021-11388, 2021-0957
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT05109494
- Acronym / sponsor ID
- 2021-0957
- Conditions
- Soft Tissue Sarcoma
- Keywords
- hypofractionated, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Administrative
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.
Detailed description
Standard treatment for soft tissue sarcomas is a combination of radiation therapy and surgery. Radiation therapy is usually done prior to the surgical removal of the tumor. Most commonly, conventionally fractionated radiotherapy is used for soft tissue sarcomas, in which radiation therapy is given over 25 treatments in a time period of approximately 5 weeks.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized by the University of Wisconsin clinical trials team to conventional versus hypofractionated RT. Randomization will be blocked to maintain balance over time, with blocks randomly assigned to sizes of 4 or 6. The randomization will take into account receipt of immunotherapy, to allow for a balance of patients in both arms.
| Arm | Type | Receives |
|---|---|---|
| Conventional Fractionated | Active comparator | Radiation: Conventional Fractionatedradiation 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 |
| Hypofractionated | Experimental | Radiation: Hypofractionatedthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
- No prior sarcoma-directed chemotherapy or radiotherapy
- Age ≥ 18 years
- Karnofsky performance status ≥ 60
- Able to understand and sign an informed consent
Key exclusion criteria (2 listed)
- Pregnant
- Unable to undergo imaging or positioning necessary for radiotherapy planning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Fractionated50 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. | Radiation | Conventional Fractionated |
| Hypofractionated27.5 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 | Radiation | Hypofractionated |
Primary outcome
Pathologic Necrosis Score on Surgical Pathology Report
Time frame: up to 12 weeks from randomization
scores range from 0 to 2, lower scores mean there was less dying tissue present
6 secondary outcomes
Incidence of Surgical Margin Status R0, R1, and R2
Time frame: up to 12 weeks from randomization
Incidence of acute wound healing complications up to 120 days after surgery
Time frame: up to 6 months from randomization (up to 120 days after surgery)
Incidence of secondary operation for wound repair
Time frame: up to 6 months from randomization (up to 120 days after surgery)
Incidence of Late Toxicity
Time frame: up to 2 years plus or minus 3 months
Progression Free Survival (PFS)
Time frame: up to 5 years
Rate of Local Tumor Recurrence
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Morris, MD, PhD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional Fractionated and Hypofractionated in people with Soft Tissue Sarcoma, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Necrosis Score on Surgical Pathology Report (time frame: up to 12 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.