Pre-Surgery Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Metastases, Rhabdomyosarcoma, Osteosarcoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a shorter, more intense form of radiation therapy (hypofractionated radiation therapy) before surgery affects wound healing in people with soft tissue sarcoma. Soft tissue sarcoma is a type of cancer that can occur in the arms, legs, hands, feet, or the surface of the trunk, and the cancer must be removable through surgery. The researchers aim to determine if this radiation approach can help patients with localized sarcomas that haven't spread. This trial might suit someone newly diagnosed with this type of cancer in those areas, who hasn't had prior radiation in the same spot. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hypofractionated radiation therapy is safe for treating soft tissue sarcoma?

Research has shown that hypofractionated radiation therapy, involving shorter treatment times with larger doses, is generally well-tolerated by patients with soft tissue sarcoma. Studies have found this method to be as safe and effective as traditional, longer radiation schedules. Participants in past studies reported few serious side effects, indicating it is a manageable option for those preparing for surgery. This treatment has been used successfully in similar conditions, reinforcing its safety. While some risk of side effects exists, evidence supports its use as a safe treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatment for soft tissue sarcoma, which typically involves longer courses of radiation therapy, hypofractionated radiation therapy delivers higher doses of radiation in a shorter period of time. This means patients receive their entire course of radiation over just three weeks, with fewer sessions overall. Researchers are excited because this approach could potentially reduce the time to surgery and improve patient convenience without compromising effectiveness. Additionally, this method may enhance the precision of radiation delivery, potentially reducing side effects and improving outcomes.

What evidence suggests that hypofractionated radiation therapy is effective for soft tissue sarcoma?

Research has shown that hypofractionated radiation therapy, which involves delivering larger doses of radiation over fewer days, can effectively treat soft tissue sarcomas. Studies have found that this method helps control cancer in the treated area, preventing growth or spread. Evidence supports its safety and effectiveness when used before surgery. In this trial, patients will undergo hypofractionated radiation therapy followed by surgical resection. Previous trials have demonstrated good results without a significant increase in side effects compared to traditional radiation methods. Overall, hypofractionated radiation therapy is becoming a more popular choice for pre-surgery treatment of soft tissue sarcomas. ^{1 2 6 7 8}

Who Is on the Research Team?

Safia K. Ahmed

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with a type of cancer called soft tissue sarcoma in the arms, legs, or superficial trunk. It's for those who can have surgery to remove it and haven't had radiation in that area before. Participants need to be able to fill out questionnaires, use birth control if they can have children, and come back for follow-ups.

Inclusion Criteria

Ability to complete questionnaire(s) by themselves or with assistance

You are expected to live for at least 6 more months.

Patients capable of childbearing must use adequate contraception

Exclusion Criteria

I am of childbearing age and not using birth control.

My cancer is one of the following types: rhabdomyosarcoma, soft tissue osteosarcoma, soft tissue Ewing sarcoma, or it is benign.

I've had radiation therapy before on the same area where my sarcoma is now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo hypofractionated radiation therapy once daily over 3 weeks for a total of 15 fractions

3 weeks

Surgical Resection

Surgical resection is performed within 3-6 weeks after completion of radiation therapy

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 4-8 weeks, every 3-4 months for years 1-2, and every 6 months for years 3-5

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• Resection

Trial Overview The study tests hypofractionated radiation therapy given over fewer days but at higher doses each day before surgery. The goal is to see if this shorter treatment reduces wound problems after surgery compared to traditional longer treatments.

How Is the Trial Designed?

Group I: Treatment (hypofractionated radiation therapy, resection) Experimental Treatment 4 Interventions

Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 18 geriatric patients with high-risk soft tissue sarcomas, hypofractionated radiotherapy (25 Gy in 5 fractions) was well tolerated, with 17 out of 18 patients completing the treatment as planned.

The treatment showed a manageable wound healing complication rate and no isolated local recurrences, suggesting that hypofractionated radiotherapy could be a feasible alternative for frail patients who cannot undergo standard therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. Potkrajcic, V., Traub, F., Hermes, B., et al.[2022]

In a study of 16 patients with soft tissue sarcoma, preoperative hypofractionated radiation therapy (30 Gy in 5 fractions) followed by immediate surgical resection resulted in no local failures and a median time of 20 days from biopsy to treatment completion.

Wound healing complications occurred in 31% of patients, with only 19% requiring additional surgery, indicating that this treatment approach has a favorable safety profile in terms of wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. Parsai, S., Lawrenz, J., Kilpatrick, S., et al.[2022]

In a phase II study involving 32 patients with soft tissue sarcomas, a 5-fraction hypofractionated preoperative radiation therapy regimen resulted in no local recurrences and a 3-year overall survival rate of 82.2%.

While the treatment showed excellent local control and survival outcomes, 25% of patients experienced major acute postoperative wound complications, indicating a need for careful monitoring of toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Bedi, M., Singh, R., Charlson, JA., et al.[2022]

Preoperative hypofractionated radiotherapy (HFRT) for soft tissue sarcomas (STS) shows comparable local control rates and similar or lower toxicity compared to traditional normofractionated radiotherapy, based on a systematic review of 13 studies including phase II trials and retrospective analyses.

Shortening the duration of preoperative radiotherapy may improve treatment adherence and cost-effectiveness without increasing adverse effects, making HFRT a promising option for patients with high-grade STS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. Roohani, S., Ehret, F., Kobus, M., et al.[2022]

In a study of 272 patients with soft tissue sarcomas, hypofractionated preoperative radiotherapy (5 Gy per fraction) demonstrated similar local control rates (81%) compared to conventional radiotherapy, suggesting it is an effective treatment option.

The treatment was associated with manageable early toxicity, with 42% of patients experiencing some form of treatment-related side effects, and only 7% requiring surgical intervention for complications, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Koseła-Paterczyk, H., Szacht, M., Morysiński, T., et al.[2018]

A phase 2 trial involving 120 patients with non-metastatic soft tissue sarcomas showed that a shorter, moderately hypofractionated preoperative radiotherapy regimen (42.75 Gy in 15 fractions) resulted in a major wound complication rate of 31%, which is comparable to the historical rate of 35% for standard treatment.

The study found no significant acute radiation toxicity (grade 3 or worse) during or shortly after treatment, indicating that this hypofractionated approach is safe and may offer a more convenient alternative to traditional radiotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. Guadagnolo, BA., Bassett, RL., Mitra, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987773/

Hypofractionated Radiotherapy for Soft Tissue Sarcomas The growing body of evidence suggests that preoperative hypofractionated radiotherapy can achieve favorable local control and survival outcomes ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02555

5-Day Hypofractionated Radiotherapy before Surgery for ... This phase II trial tests the safety, side effects, and effectiveness of 5-day hypofractionated radiotherapy (HFRT) prior to surgery (preoperative)

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814024043068

Hypofractionated accelerated radiation dose-painting ... HARD regimen significantly improves LC for unresectable STS without a significant increase in toxicity, when compared to a standard fractionated approach.

4. redjournal.org redjournal.org/article/S0360-3016(24)02975-4/abstract

Hypofractionated Preoperative Radiation Therapy for Soft ... There is a growing body of evidence supporting hypofractionation as safe and effective in the preoperative treatment of STS.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03972930

Hypofractionated Radiotherapy for Soft Tissue Sarcomas The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03972930

Hypofractionated Radiotherapy for Soft Tissue Sarcomas The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33798613/

Safety, feasibility, and early oncologic outcomes of a phase ... The aim of this study was to evaluate neoadjuvant chemotherapy (ChT) plus concomitant hypofractionated RT (hypo-RT) in local and distant disease relapse.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814022045881

Early outcomes of ultra-hypofractionated preoperative ... This critical review aims to summarize the relevant published data regarding hypofractionation regimens for preoperative radiation therapy (RT) prior to ...