Short-Course Radiotherapy + Surgery for Soft Tissue Sarcoma

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt-Ingram Cancer Center

Disqualifiers: Prior radiation, Pregnancy, Collagen vascular disease

Stay on Your Current Meds You can continue your current medications while participating

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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for soft tissue sarcoma, a cancer that develops in the body's connective tissues. The researchers aim to determine if a shorter course of hypofractionated radiotherapy, administered over 5 or 15 days before surgery, is as effective as the standard 5-week course. They hope this method will not increase wound complications or the risk of cancer recurrence at the original site. Individuals with a confirmed diagnosis of soft tissue sarcoma in areas such as the limbs or chest, who can undergo both radiation and surgery, may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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 using hypofractionated radiotherapy before surgery for soft tissue sarcoma is generally safe. For ultra-hypofractionated radiotherapy, studies indicate that about 30.6% of patients experience major wound complications, a rate similar to traditional radiation treatments. Another study found that patients tolerated this therapy well, with no increased risks compared to usual methods.

For moderately hypofractionated radiotherapy, long-term studies have shown it to be safe and effective. Specifically, one study found that 93% of patients did not experience cancer recurrence in the treated area after four years. Overall, this approach is considered safe and compares well with standard treatments.

These findings suggest that both types of hypofractionated radiotherapy are well-tolerated options for those considering this treatment in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for soft tissue sarcoma?

Researchers are excited about the use of hypofractionated radiotherapy (HRT) for soft tissue sarcoma because it offers a shorter treatment schedule compared to traditional radiotherapy. Unlike standard radiotherapy, which may take several weeks, HRT involves delivering higher doses of radiation over fewer sessions. This not only reduces the overall treatment time but also aims to maintain, or even improve, the effectiveness of the therapy. The UH HRT approach involves just five sessions, while the MH HRT extends to fifteen, giving researchers the opportunity to compare different intensities and durations. By potentially minimizing patient inconvenience and maintaining treatment efficacy, HRT could be a game-changer for those battling soft tissue sarcoma.

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

This trial will compare two approaches of hypofractionated radiotherapy for treating soft tissue sarcomas. Group I participants will receive ultra-hypofractionated radiotherapy (UH HRT), involving a very short course of radiotherapy. Group II participants will receive moderately hypofractionated radiotherapy (MH HRT), involving a moderately short course. Studies have shown that both ultra-hypofractionated and moderately hypofractionated radiotherapy can control cancer as effectively as traditional, longer treatments. Early results for ultra-hypofractionated radiotherapy suggest it controls cancer and improves survival rates similarly. Specifically, one study on the moderately hypofractionated approach found a high rate of preventing local cancer recurrence, with 93% of patients remaining cancer-free in the treated area over four years. Both treatments aim to shorten the duration of radiation therapy without increasing the risk of wound problems or cancer recurrence. ^{2 3 6 7 8}

Who Is on the Research Team?

Eric Shinohara, MD

Principal Investigator

Vanderbilt Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of soft tissue sarcoma located in the limbs, pelvis, chest wall or non-retroperitoneal abdominal wall. Participants should be able to perform daily activities (ECOG status 0-2) and must be fit for radiation treatment and surgery. It's not open to those who've had prior radiation in the same area, have metastatic disease, are pregnant, will receive neoadjuvant chemotherapy, or have certain diseases that increase radiation side effects.

Inclusion Criteria

My cancer is a type of soft tissue sarcoma located in my limbs, pelvis, chest wall, or abdominal wall.

I can take care of myself and am up and about more than half of the day.

I am able to undergo radiation treatment and surgery.

Exclusion Criteria

I have had radiation treatment on the same area before.

I am scheduled for chemotherapy before surgery.

I have a genetic condition that increases my risk of side effects from radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo neoadjuvant hypofractionated radiotherapy (HRT) for either 5 or 15 fractions

1-3 weeks

Surgery

Participants undergo surgical resection following completion of radiotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Minimum of 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiotherapy

Trial Overview The study is testing two shorter courses of hypofractionated radiotherapy (5 or 15 days) followed by surgical removal of the tumor in patients with soft tissue sarcoma. This approach is compared against the traditional longer course (5 weeks) to see if it can reduce treatment time without increasing wound complications or chances of cancer returning.

How Is the Trial Designed?

Group I: Group II (MH HRT) Experimental Treatment 3 Interventions

Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Group II: Group I (UH HRT) Experimental Treatment 3 Interventions

Patients undergo HRT daily for a total of 5 fractions followed by surgery.

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?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Published Research Related to This Trial

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 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]

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]

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]

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 ... We investigated the rate of WC in a cohort of soft tissue sarcoma patients treated with a moderately hypofractionated course of preoperative RT.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.35542?af=R

Moderately hypofractionated, preoperative radiotherapy in ... The median follow-up was 43 months (interquartile range, 37–52 months), and the 4-year local recurrence-free survival rate was 93%. Overall RT- ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04538-4/pdf

Balancing the dose The outcomes of ultra- hypofractionated radiotherapy are still premature and heterogeneous, making it difficult to draw conclusions about this ...

5. 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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39192597/

Updated local control, late toxicities, and patient-reported ... Conclusions: Long-term follow up suggests that moderately hypofractionated preoperative RT for patients with STS is safe and effective. Higher ...

7. mdpi.com mdpi.com/2072-6694/17/7/1170

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 ...

8. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00638-6/abstract

Hypofractionated, 3-week, preoperative radiotherapy for ... Interpretation. Moderately hypofractionated preoperative radiotherapy delivered to patients with soft tissue sarcomas was safe and could ...