Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnant, Recent chemotherapy, Prior radiation, 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: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called hypofractionated radiotherapy for individuals with soft tissue sarcoma, a cancer that can develop anywhere in the body. The goal is to determine if this treatment can effectively target the cancer while preserving nearby healthy tissues. The trial seeks participants diagnosed with this type of sarcoma who either cannot undergo surgery or have opted against it. Participants will assist researchers in evaluating whether this treatment surpasses traditional methods in controlling cancer growth. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy or systemic anti-cancer treatment in the two weeks before starting the trial.

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

Research shows that hypofractionated radiotherapy is generally safe and effective for treating soft tissue sarcomas. Studies have found it provides similar results to standard treatments in controlling tumors and managing side effects. Early results indicate it is safe for use before surgery. Long-term follow-ups suggest patients tolerate this treatment well, with manageable side effects. Overall, the treatment appears promising, but further research is needed to fully understand its safety for different sarcoma types and their locations in the body. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for soft tissue sarcoma?

Hypofractionated radiotherapy is unique because it offers a potentially faster and more convenient treatment option for soft tissue sarcoma compared to traditional radiotherapy. Unlike standard treatments that may require many sessions over several weeks, this approach delivers higher doses in just 3-8 fractions over a maximum of 8 weeks, which could mean fewer hospital visits and a quicker treatment timeline for patients. Researchers are excited about this method because it may maintain or even improve tumor control while reducing the overall time burden on patients, potentially leading to better quality of life during treatment.

What evidence suggests that hypofractionated radiotherapy might be an effective treatment for soft tissue sarcoma?

Research has shown that hypofractionated radiotherapy, which participants in this trial will receive, could effectively treat soft tissue sarcomas. Some studies indicate it controls cancer as well as current standard treatments. This method delivers higher doses of radiation in fewer sessions, potentially reducing damage to nearby healthy tissues. Early results suggest that patients experience similar outcomes with less stress on their bodies. However, more information is needed because sarcomas are rare and vary widely. Overall, hypofractionated radiotherapy appears to be a promising and safe option for treating soft tissue sarcomas. ^{1 6 7 8 9}

Who Is on the Research Team?

Zachary Morris, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of soft tissue sarcoma that can't be removed by surgery or has spread, and who are fit enough to undergo the treatment (Karnofsky performance status > 60). It's not suitable for pregnant individuals, those who've had recent chemotherapy, or anyone unable to have imaging required for planning radiotherapy.

Inclusion Criteria

My soft tissue sarcoma is confirmed by biopsy and cannot be removed by surgery but can be treated with targeted radiotherapy.

Able to understand and sign an informed consent form

I can care for myself but may not be able to do active work.

Exclusion Criteria

I haven't had chemotherapy or cancer treatment in the last 2 weeks.

Pregnant

I cannot undergo scans or positioning needed for planning radiotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated radiotherapy with 3-8 fractions, with a maximum dose of 60 Gy over 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for progression-free survival and overall survival

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiotherapy

Trial Overview The study tests Hypofractionated Radiotherapy on soft tissue sarcomas. This approach delivers high doses of radiation in fewer sessions while aiming to minimize damage to surrounding healthy tissues. The goal is better control over tumor growth compared to traditional methods.

How Is the Trial Designed?

Group I: Hypofractionated Radiotherapy for Soft Tissue Sarcoma Experimental Treatment 1 Intervention

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.

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

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

Neoadjuvant ultra-hypofractionation radiotherapy for soft tissue sarcoma shows a low wound complication rate of 30%, indicating it is a safe treatment option.

The treatment also demonstrates high efficacy with an 87% R0 resection rate and a 96% local control rate over two years, suggesting it effectively prepares patients for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies. Kao, YS.[2023]

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 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 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]

Hypofractionated radiotherapy, used in 30 patients with non-metastatic soft tissue and bone sarcomas, demonstrated a 1-year overall survival rate of 75% and a 2-year local recurrence-free survival rate of 48%, indicating its efficacy in managing these cancers.

The treatment was generally safe, with only one case of severe late toxicity (grade 3 trismus), suggesting that hypofractionated radiotherapy can be a viable option for both primary treatment and reirradiation in sarcoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for non-metastatic bone and soft tissue sarcomas. Yuce Sari, S., Cengiz, M., Dauletkazin, A., et al.[2019]

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]

Citations

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

Hypofractionated Radiotherapy for Soft Tissue Sarcomas Hypofractionated radiotherapy may offer similar local control and toxicity outcomes in the management of soft tissue sarcomas (STS) compared to standard ...

2. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/studying-ultra-hypofractionated-radiotherapy-for-soft-tissue-sarcoma

Studying Ultra-Hypofractionated Radiotherapy for Soft Tissue ... Research team found ultra-hypofractionated radiotherapy improved on the current standard of care for treating soft tissue sarcoma.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03972930

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424001258

Preoperative Ultrahypofractionated Radiation Therapy for ... Increasing reports on mild hypofractionated or uhRT data from phase 1/2 studies and patient cohorts consistently confirm comparable outcomes with preoperative ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04538-4/pdf

Balancing the dose Based on descriptive data, the MWC rates of the ultra-hypofractionated group did not exceed 41 %, with one study reporting a rate of 41 % and ...

6. 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.

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

Early outcomes of ultra-hypofractionated preoperative ... Original Article. Early outcomes of ultra-hypofractionated preoperative radiation therapy for soft tissue sarcoma followed by immediate surgical resection.

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04538-4/fulltext

Balancing the dose: A meta-analysis of preoperative ... Radiotherapy, both preoperative and postoperative, has been shown to improve local control. Hypofractionation has shown promising results in other malignancies ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39192597/

Updated local control, late toxicities, and patient-reported ... Long-term follow up suggests that moderately hypofractionated preoperative RT for patients with STS is safe and effective.