Soft Tissue SarcomaPhase 2NCT03972930

Hypofractionated Radiotherapy for Soft Tissue Sarcomas

A Phase 2 study testing Hypofractionated Radiotherapy in people with Soft Tissue Sarcoma, run by University of Wisconsin, Madison at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Soft Tissue Sarcoma
What is being tested?: Hypofractionated Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 11 Jun 2019to Dec 2027
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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, 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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin
Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: Phase 2 Trial of 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.

Conditions: Soft Tissue Sarcoma
Being tested: Hypofractionated Radiotherapy
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.

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

Study groups in NCT03972930
Study group	Role	What they receive
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. Receives: Radiation: Hypofractionated Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With 2-year Local Control
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.
Measured: up to 2 years

Secondary outcomes (7)

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.
Measured: up to 2 years
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.
Measured: up to 5 years
Complete Response Rate
The complete response (CR) rate will be reported with an exact 95% CI.
Measured: up to 5 years
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.
Measured: up to 5 years
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.
Measured: up to 5 years
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade
Unique toxicities tabulated by type and grade.
Measured: up to 8 weeks
Incidence of Long Term Toxicity
Tabulated by type and grade.
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.

11 Jun 2019Dec 2027

First posted4 Jun 2019
Study start11 Jun 2019
Primary completion28 Nov 2024
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03972930
Sponsor's protocol ID: 2019-0360
Other IDs: 2019-0360, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, NCI-2019-03768, Protocol Version 5/5/2021
Status last verified: Jun 2026
First submitted: 31 May 2019
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)

All Soft Tissue Sarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Trial of Hypofractionated Radiotherapy for Soft Tissue Sarcomas
ClinicalTrials.gov ID: NCT03972930
Acronym / sponsor ID: 2019-0360
Conditions: Soft Tissue Sarcoma
Keywords: Hypofractionated Radiotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 48 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 11 Jun 2019 (actual)
Primary completion: 28 Nov 2024 (actual)
Study completion: Dec 2027 (estimated)
First posted: 4 Jun 2019 (actual)
Results: Posted 12 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hypofractionated Radiotherapy for Soft Tissue Sarcoma	Experimental	Radiation: Hypofractionated RadiotherapyParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

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
Hypofractionated RadiotherapyHypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.	Radiation	Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Primary outcome

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.

7 secondary outcomes

Proportion of Participants With 2-year Local Control: Primary Site vs Metastatic Site
Time frame: up to 2 years
Proportion of Participants With 5-year Local Control: Primary Site vs Metastatic Site
Time frame: up to 5 years
Complete Response Rate
Time frame: up to 5 years
Progression Free Survival
Time frame: up to 5 years
Overall Survival
Time frame: up to 5 years
Acute Toxicity Tabulated as the Number of Participants Who Experienced Each Adverse Event by Grade
Time frame: up to 8 weeks
Incidence of Long Term Toxicity
Time frame: up to 5 years

Results and safety

Results posted to the registry on 12 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypofractionated Radiotherapy for Soft Tissue Sarcoma	48	48

Primary outcome: Proportion of Participants With 2-year Local Control

Time frame: up to 2 years. Number. Unit: proportion of participants

Measure	Hypofractionated Radiotherapy for Soft Tissue Sarcoma n = 48
Value	0.352

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Acute toxicities were collected up to 8 weeks and are reported here with Primary Results. All-cause mortality and serious adverse event (SAE) data were collected up to 2 years. Data collection for late toxicities will be collected for up to 5 years. Adverse Events will be amended with late toxicity data when data collection is complete.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypofractionated Radiotherapy for Soft Tissue Sarcoma	1 of 48 (2.1%)	23 of 48 (47.9%)	27 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Soft Tissue Sarcoma

Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Not yet recruiting
Large Language Model Support for CTEPH Differential Diagnosis
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)

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

University of Wisconsin, Madison

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 Hypofractionated Radiotherapy 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 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?

Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Participants With 2-year Local Control (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972930.

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 2 Jul 2026.