Soft Tissue SarcomaPhase 2NCT06905132
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
A Phase 2 study testing Hypofractionated Radiation Therapy in people with Soft Tissue Sarcoma, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. 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?
- Hypofractionated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 27 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Willingness and provision of informed consent via signed and dated copy.
- Histologically confirmed STS of extremity or trunk.
- Male or female, aged greater than or equal to 18 years old
- ECOG performance status 0-3
- Meets screening criteria for receipt of radiotherapy.
- Deemed eligible for wide local excision.
- Patient and/or physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and/or physical burden of travel for daily treatments, financial burden of time away from work or caregiving.
Who cannot join
- Distant metastatic disease
- Prior radiation therapy in the proposed treatment area
- Simultaneous treatment of another malignancy
- Women who are pregnant or plan to become pregnant during the period of radiation therapy
- Planned concurrent administration of chemotherapy and radiation therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29401
Jennifer Harper, MD
About this study
Official title: Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
Read the detailed description
This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Hypofractionated Radiation Therapy
- Keywords
- STS, HFRT, SFRP2
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Participants will receive preoperative 5-day HFRT (30Gy/5fx once daily over consecutive weekdays) followed by "standard of care" wide local excision 2-6 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Not described Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFRT Safety
Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.
Measured: 6 months
Secondary outcomes (2)
Treatment Response
Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.
Measured: 6 months
Safety Profile
Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion27 Mar 2029 (estimated)
- Study completion27 Mar 2030 (estimated)
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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Harper, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905132
- Sponsor's protocol ID
- 104131
- Other IDs
- Pro00141818
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
- ClinicalTrials.gov ID
- NCT06905132
- Acronym / sponsor ID
- 104131
- Conditions
- Soft Tissue Sarcoma
- Keywords
- STS, HFRT, SFRP2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 27 Mar 2029 (estimated)
- Study completion
- 27 Mar 2030 (estimated)
- First posted
- 1 Apr 2025 (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.
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
Detailed description
This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Radiation: Hypofractionated Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willingness and provision of informed consent via signed and dated copy.
- Histologically confirmed STS of extremity or trunk.
- Male or female, aged greater than or equal to 18 years old
- ECOG performance status 0-3
- Meets screening criteria for receipt of radiotherapy.
Key exclusion criteria (5 listed)
- Distant metastatic disease
- Prior radiation therapy in the proposed treatment area
- Simultaneous treatment of another malignancy
- Women who are pregnant or plan to become pregnant during the period of radiation therapy
- Planned concurrent administration of chemotherapy and radiation therapy
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 Radiation TherapyParticipants will receive preoperative 5-day HFRT (30Gy/5fx once daily over consecutive weekdays) followed by "standard of care" wide local excision 2-6 weeks later. | Radiation | Hypofractionated Radiation Therapy |
Primary outcome
HFRT Safety
Time frame: 6 months
Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.
2 secondary outcomes
Treatment Response
Time frame: 6 months
Safety Profile
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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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.
Jennifer Harper, MD principal investigator
Medical University of South Carolina
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 Radiation Therapy in people with Soft Tissue Sarcoma, run by Medical University of South Carolina 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFRT Safety (time frame: 6 months). 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 30 Mar 2026.