Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Overseen By Beverly Guadagnolo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous radiation, Metastases, Pregnancy

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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy method for individuals with soft tissue sarcoma, a cancer in the body's soft tissues like muscles and fat. The goal is to determine if larger radiation doses over a shorter period before surgery can be more effective and cause fewer side effects. Participants should have a sarcoma in the limbs or shallow body areas that can be surgically removed. This approach might be more convenient and lead to fewer complications than longer radiation courses. Ideal participants are those without cancer spread who can undergo surgery to remove the tumor. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in cancer therapy.

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. Please consult with the trial coordinators or your doctor for guidance.

Is there any evidence suggesting that hypofractionated radiation therapy is likely to be safe for humans?

Research has shown that hypofractionated radiation therapy could safely treat soft tissue sarcomas. Studies have found that this method offers similar cancer control and side effects compared to standard radiation treatments, meaning it does not cause more side effects than usual treatments.

One study discovered that delivering this type of radiation over a shorter period, such as five days before surgery, is as safe and manageable as the standard five-week treatment. Another study found that this approach effectively prevented tumor recurrence without causing significant harm to patients.

Overall, early findings suggest that hypofractionated radiation therapy is well-tolerated and might be a convenient option for patients with soft tissue sarcoma. ^{1 2 3 4 5}

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

Hypofractionated radiation therapy is unique because it condenses the treatment into just 15 daily sessions over three weeks, compared to conventional radiation therapy that often requires several weeks of daily sessions. This shorter treatment duration can be more convenient and less taxing for patients, potentially improving their quality of life during therapy. Researchers are excited about this approach because it could maintain or even enhance the effectiveness of the treatment while minimizing the time and side effects associated with longer radiation schedules.

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

Studies have shown that hypofractionated radiation therapy, which participants in this trial will receive, can control cancer and manage side effects as effectively as standard, longer radiation treatments for soft tissue sarcomas. One study found this treatment effectively controlled the tumor. Another study reported a 23.1% rate of wound complications, suggesting it might manage such risks well. This shorter radiation method delivers high doses over a brief period, potentially offering convenience and effectiveness for patients. Initial research supports its use as a promising alternative to longer treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Beverly A. Guadagnolo

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with localized soft tissue sarcoma in limbs or superficial trunk, who can undergo surgery and have no distant cancer spread. They must be able to follow up, use contraception if capable of childbearing, and have a life expectancy over 6 months. Those previously treated with radiation at the same site or pregnant women are excluded.

Inclusion Criteria

I had a biopsy that might not have removed all cancer, but further surgery is advised.

I can take care of myself but can't do heavy physical work.

My tumor is in the soft tissue of my limbs or upper body.

Exclusion Criteria

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

I am currently pregnant.

My cancer has spread to lymph nodes or other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Every 3-4 months for 2 years, every 6 months for 3 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests a shorter course of high-dose radiation therapy before surgery compared to traditional longer courses. It aims to see if this approach reduces tumor cells effectively while causing fewer side effects and complications during wound healing.

How Is the Trial Designed?

Group I: Treatment (hypofractionated RT) Experimental Treatment 3 Interventions

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Low-load resistance training with blood flow restriction (LLRT-BFR) resulted in lower cardiac output and heart rate compared to high-load resistance training (HLRT), suggesting a potentially safer cardiovascular response during exercise.

The review included 19 randomized controlled trials focusing on healthy young individuals, indicating that while LLRT-BFR may not enhance overall acute effects compared to low-load resistance training (LLRT), it does offer specific cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of resistance exercise with blood flow restriction on cardiovascular response: a meta-analysis. Lemos, LK., Toledo Teixeira Filho, CA., Biral, TM., 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]

Hypofractionated radiation therapy (HFRT) was effective in providing durable local control and symptom relief for 73 patients with sarcoma, achieving a 1-year local control rate of 73% and a 1-year disease-specific survival rate of 59%.

HFRT was particularly beneficial for patients with oligometastatic (100% survival) and oligoprogressive disease (73% survival), with minimal acute toxicities (49% grade 1-2) and no severe late toxicities, making it a safe option for palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiation Therapy for Unresectable or Metastatic Sarcoma Lesions. Boyce-Fappiano, D., Damron, EP., Farooqi, A., et al.[2022]

A review of 21 randomized controlled trials found that Blood Flow Restriction Therapy (BFRT) combined with exercise did not significantly improve athletic performance, muscle strength, or hypertrophy compared to exercise alone.

Both immediate and long-term effects of BFRT on sprint and jump performance, as well as muscle strength and hypertrophy, showed no significant differences, suggesting that BFRT may not provide additional benefits over traditional exercise methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction therapy with exercise are no better than exercise alone in improving athletic performance, muscle strength, and hypertrophy: a systematic review and meta-analysis. Khurana, D., Dutta, N., Malik, S., et al.[2023]

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[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]

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]

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

5-Day Hypofractionated Radiotherapy before Surgery for ... HFRT has been studied in many small trials which showed similar cancer outcomes to the standard 5-week course of radiation therapy. Based on findings from these ...

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

Hypofractionated Preoperative Radiation Therapy for ... In our prospective trial, hypofractionated preoperative RT with 42.75 Gy in 15 fractions for STS had a major WC rate of 23.1%. This suggests ...

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. clinicaltrial.be clinicaltrial.be/en/details/63338?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Hypofractionated Radiotherapy for Soft Tissue Sarcomas -... Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9817485/

Hypofractionated, 3-week, preoperative radiotherapy for ... Standard preoperative radiation therapy (RT) dosing of 50 Gy in 25 fractions for soft tissue sarcoma (STS) results in excellent local control with major wound ...