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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation. Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.

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 data supports the effectiveness of the treatment Hypofractionated Radiotherapy for Soft Tissue Sarcoma?

Research suggests that hypofractionated radiotherapy (shorter, more intense radiation sessions) for soft tissue sarcoma can be effective without increasing side effects, and it may improve treatment adherence and cost-effectiveness compared to traditional methods. ^{1 2 3 4 5}

Is hypofractionated radiotherapy safe for humans?

Research shows that hypofractionated radiotherapy, used before surgery for soft tissue sarcomas, does not increase the risk of side effects compared to traditional methods. It may even improve treatment adherence and be more cost-effective, making it a generally safe option for patients. ^{1 3 4 5 6}

How is hypofractionated radiotherapy different from other treatments for soft tissue sarcoma?

Hypofractionated radiotherapy for soft tissue sarcoma is unique because it shortens the treatment time by delivering higher doses of radiation in fewer sessions, which can be especially beneficial for older or frail patients who may struggle with longer treatment schedules. This approach aims to maintain effectiveness while potentially reducing side effects and improving patient adherence compared to the traditional, longer radiotherapy courses. ^{1 2 4 5 6}

Research Team

Zachary Morris, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. 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]

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. France pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for non-metastatic bone and soft tissue sarcomas. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. Poland pubmed.ncbi.nlm.nih.gov

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