Hypofractionated vs Conventional Radiation Therapy for Soft Tissue Sarcoma

Recruiting in Palo Alto (17 mi)

Overseen by Zachary Morris, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnant, Imaging issues, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.

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.

What data supports the effectiveness of hypofractionated vs conventional radiation therapy for soft tissue sarcoma?

Research shows that hypofractionated radiation therapy, which uses fewer but higher doses of radiation, can be effective for treating soft tissue sarcoma, especially in situations where shorter treatment times are needed, such as during the COVID pandemic or for elderly patients. Studies have reported positive outcomes with this approach, suggesting it may be a viable alternative to conventional radiation therapy. ^{1 2 3 4 5}

Is hypofractionated radiation therapy safe for soft tissue sarcoma patients?

Research suggests that hypofractionated radiation therapy, which involves fewer but higher doses of radiation, is generally safe for soft tissue sarcoma patients. Studies indicate that it does not increase toxicity rates compared to conventional methods and may even improve treatment adherence and cost-effectiveness. ^{1 3 4 6 7}

How does hypofractionated radiation therapy differ from conventional treatment for soft tissue sarcoma?

Hypofractionated radiation therapy for soft tissue sarcoma involves delivering higher doses of radiation in fewer sessions compared to the conventional approach, which typically requires daily treatments over several weeks. This method can shorten the overall treatment time, making it more feasible for patients who may have difficulty with prolonged treatment schedules, such as the elderly or those with limited access to healthcare facilities. ^{1 2 3 4 5}

Research Team

Zachary Morris, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Conventional Fractionated (Radiation Therapy)
• Hypofractionated (Radiation Therapy)

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.

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018]

2. France pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [2022]

7. England 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. [2023]