Short-course Radiation Therapy for Sarcoma

Overseen By Jackie Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Active malignancy, Prior irradiation, Pre-op chemotherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using hypofractionated radiation therapy for individuals with soft tissue sarcoma, a cancer in the body's connective tissues. The researchers aim to determine if delivering higher doses of radiation over a shorter period can kill more cancer cells while minimizing side effects before surgery. Suitable candidates have a confirmed diagnosis of intermediate or high-grade sarcoma that is surgically removable and have not received prior radiation treatment to the area. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that pre-operative chemotherapy is not allowed, so if you are on chemotherapy, you may need to stop it before joining the trial.

What prior data suggests that hypofractionated radiation therapy is safe for treating soft tissue sarcomas?

A previous study found that administering radiation in larger doses over a shorter period was well-tolerated by people with soft tissue sarcomas. Research shows that this method can be as safe and effective as traditional, longer radiation treatments. Importantly, studies indicate that patients did not experience more severe side effects with this shorter treatment compared to the standard one. While every treatment carries some risks, this therapy is considered safe for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for sarcoma, which often involve extended courses of radiation therapy over several weeks, hypofractionated radiation therapy is unique because it delivers larger doses of radiation over just five days. This condensed schedule can significantly reduce the overall treatment time for patients, making it more convenient and less disruptive to their daily lives. Researchers are excited about this approach because it could maintain or even enhance the effectiveness of radiation therapy while minimizing the burden on patients. Additionally, this treatment allows for surgery to follow in a flexible timeframe of 2 to 12 weeks, potentially improving surgical outcomes and recovery.

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

Research has shown that hypofractionated radiation therapy, which participants in this trial will receive, can effectively treat soft tissue sarcomas. This method delivers higher doses of radiation over a shorter period and works as well as the traditional 5-week radiation schedule. It controls the tumor by preventing growth or spread in the treated area. Additionally, evidence suggests it may cause fewer side effects than the longer treatment. Overall, it is considered a safe and effective way to prepare soft tissue sarcomas for surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Anusa Kalbasi, M.D.

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a certain type of cancer called soft tissue sarcoma in the limbs or trunk. They should be relatively active and healthy (KPS >= 70 or ECOG 0-2), not pregnant if female, and have a tumor that can be surgically removed. Those with recurring cancer are eligible if they haven't had radiation before; however, people actively treating another cancer or who've had pre-op chemo aren't.

Inclusion Criteria

My cancer is a type of sarcoma found in my limbs or trunk.

My sarcoma has come back and I haven't had radiation before.

I can care for myself and perform normal activities.

Exclusion Criteria

I am currently being treated for another cancer.

I have received chemotherapy before surgery.

I have had radiation therapy on the area that needs treatment now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days

1 week

5 visits (in-person)

Surgery

Patients undergo surgery 2-12 weeks after completion of radiation therapy

2-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 3 months and then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests hypofractionated radiation therapy given over five days before surgery for soft tissue sarcomas. This approach uses higher doses in fewer sessions compared to traditional radiation, aiming to kill more tumor cells while potentially causing fewer side effects.

How Is the Trial Designed?

Group I: Treatment (hypofractionated radiation therapy) Experimental Treatment 4 Interventions

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

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?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Sarcoma Alliance for Research through Collaboration

Collaborator

Trials

26

Recruited

2,000+

Tower Cancer Research Foundation

Collaborator

Trials

3

Recruited

100+

Sarcoma Foundation of America

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

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 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]

Two patients with large high-grade sarcomas successfully underwent hypofractionated radiation therapy (HFRT) combined with chemotherapy before surgery, and neither experienced post-operative wound complications, which is notable given the typical complication rate of one in three for standard treatments.

This case suggests that HFRT may be a promising alternative to traditional radiation regimens, warranting further investigation into its safety and efficacy in preventing wound complications in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy and wound healing after massive sarcoma resection: Case report and review of the literature. Allen, M., Silvino, D., Kamrava, M., et al.[2021]

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]

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]

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814024043068

Hypofractionated accelerated radiation dose-painting ... Unresected sarcoma outcomes are often limited to the RT doses safely achieved with SFT, with various thresholds of dose demonstrating improved outcomes: >48–50 ...

4. 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.

5. advancesradonc.com advancesradonc.com/article/S2452-1094(22)00020-3/fulltext

Hypofractionated Radiation Therapy for Unresectable or ... Using HFRT we achieved 1- and 2-year LC rates of 73% and 47%, respectively. It is difficult to draw comparisons of HFRT to conventional ...

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424000101

Novel Definitive Hypofractionated Accelerated Radiation ... With a median follow-up of 33.4 months, there was a 3-year locoregional control rate of 100%. The 3-year overall and progression-free survival were 44.9% and ...