NCT06905132 · Medical University of South Carolina
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
What this study is about
The purpose of this research study is to preserve healthy tissue around the cancer on the treatment group$1(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
View original scientific description
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.
Interventions
RADIATION
Hypofractionated Radiation Therapy
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Charleston, South Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations