Hypofractionated vs Conventional Radiation Therapy for Soft Tissue Sarcoma

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnant, Imaging issues, 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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of two types of radiation therapy given before surgery for treating soft tissue sarcomas. It compares conventional fractionated radiation, administered daily over about seven weeks, to hypofractionated radiation, given more frequently over about three weeks. This study may suit those diagnosed with soft tissue sarcoma in areas like the arm, leg, or head, who have not received prior chemotherapy or radiotherapy for sarcoma, and are eligible for surgery. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in sarcoma treatment.

Do I need to stop my current medications for this trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated radiation therapy can be safe for people with soft tissue sarcoma. One study found that using this type of radiation before surgery effectively controlled the cancer and was safe. Another study showed that this method did not cause more serious side effects than traditional methods.

Conventional fractionated radiation therapy, used for a long time, is generally well-tolerated. It involves more frequent treatments over a longer period, which some patients find easier to manage.

In summary, previous studies have demonstrated the safety of both hypofractionated and conventional radiation therapies. Patients reported manageable side effects, making these options worth considering for those interested in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy methods for soft tissue sarcoma because they offer different schedules and potential benefits compared to the traditional approach. Conventional fractionated radiation therapy involves daily treatments over about seven weeks, while the hypofractionated approach condenses treatments into a maximum of three weeks, with sessions happening every day or every other day. This shorter treatment duration could mean less time spent in therapy and possibly quicker recovery times, which is a significant advantage for patients. Additionally, both approaches aim to effectively prepare the tumor site for surgery, which occurs within 5-14 days after completing radiation. These variations in treatment delivery are what researchers are eager to explore, as they could lead to better patient experiences and outcomes.

What evidence suggests that this trial's treatments could be effective for soft tissue sarcoma?

This trial will compare hypofractionated radiotherapy with conventional fractionated radiotherapy for treating soft tissue sarcomas. Research has shown that hypofractionated radiotherapy can effectively treat soft tissue sarcomas. Studies have found that it controls the cancer and has side effects similar to the usual treatment. One study found it was just as effective at controlling the cancer as standard treatments. Another study reported a 23.1% rate of wound complications, indicating it is not worse than the usual treatment. Hypofractionated radiotherapy is also considered safe and effective for patients whose tumors cannot be removed. This treatment shows promise for people with soft tissue sarcomas. ^{1 2 3 5 6}

Who Is on the Research Team?

Zachary Morris, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with soft tissue sarcoma who haven't had previous treatments, are fit for surgery, and have good organ function. They must be able to undergo radiation therapy planning and sign consent. Pregnant individuals or those unable to undergo necessary imaging are excluded.

Inclusion Criteria

My blood and kidney tests meet the required levels.

I have a confirmed soft tissue sarcoma in my limb, trunk, or head/neck.

My doctor agrees that specific targeted radiation therapy is safe and suitable for me before surgery.

Exclusion Criteria

I cannot have scans or stay still for radiotherapy planning.

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either conventionally fractionated radiotherapy over 25 treatments in 5 weeks or hypofractionated radiotherapy over 5 treatments in 1-2 weeks

1-7 weeks

Daily visits for radiation treatment

Surgery

Surgical resection of the tumor is performed within 5-14 days after completion of radiotherapy

2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and late toxicity after treatment

up to 5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Fractionated
• Hypofractionated

Trial Overview The study compares two types of pre-surgery radiation therapies: conventional fractionated (standard approach) versus hypofractionated (fewer, higher-dose treatments). It aims to determine the safety and effectiveness of these methods in treating soft tissue sarcomas.

How Is the Trial Designed?

Group I: Hypofractionated Experimental Treatment 1 Intervention

the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT

Group II: Conventional Fractionated Active Control 1 Intervention

radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT

Conventional Fractionated is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

Approved in United States as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

Approved in Canada as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

Approved in Japan as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

Approved in China as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

Approved in Switzerland as Conventional Fractionation for:

• Soft tissue sarcomas
• Breast cancer
• Lung cancer
• Prostate cancer
• Head and neck cancers

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

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 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]

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]

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]

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]

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

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625004456

Hypofractionated Preoperative Radiation Therapy for ... The major WC rate was 23.1% with a preoperative regimen of 42.75 Gy in 15 fractions. This suggests moderate hypofractionation is not inferior compared to ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)04306-8/abstract

Hypofractionated accelerated radiation dose-painting ... The HARD regimen for unresected STS resulted in excellent local control. HARD improved local control compared to standard fractionation. HARD was safe.

4. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00219-1/fulltext

Novel Postoperative Hypofractionated Accelerated ... This study evaluates the acute toxicity of a hypofractionated accelerated RT dose-painting (HARD) approach for postoperative treatment of STS.

5. advancesradonc.com advancesradonc.com/article/S2452-1094(24)00010-1/fulltext

Novel Definitive Hypofractionated Accelerated Radiation ... The purpose of this study was to evaluate the safety and efficacy of the HARD regimen for unresected STS patients. Methods and Materials.

6. 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.