Radiotherapy for Soft Tissue Sarcoma

Overseen By HCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Disqualifiers: Metastatic disease, Prior radiation, Pregnancy, 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

Compensation: Varies

Number of Visits: 12

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of radiation therapy called Hypofractionated Radiation Therapy for treating soft tissue sarcoma in the arms or legs. The goal is to target the cancer while protecting the surrounding healthy tissue and to prevent the cancer from spreading. Individuals with confirmed soft tissue sarcoma in their limbs or trunk, who have concerns about a longer, traditional radiation schedule, might be suitable for this trial. However, it is not intended for those whose cancer has spread to other parts of their body. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that chemotherapy cannot be given at the same time as the radiation therapy.

Is there any evidence suggesting that Hypofractionated Radiation Therapy is likely to be safe for humans?

Research has shown that hypofractionated radiation therapy is generally safe for treating soft tissue sarcomas. Studies have found that it offers similar results and side effects compared to standard radiation treatments.

One study discovered that using this type of radiation before surgery is safe and might be a better choice for some patients. Another review confirmed its safety, highlighting its effectiveness in managing cancer while controlling side effects.

Overall, hypofractionated radiation therapy is well-tolerated, with increasing evidence supporting its safety for patients with soft tissue sarcomas. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hypofractionated Radiation Therapy is unique because it delivers higher doses of radiation over fewer sessions compared to traditional radiation therapy for soft tissue sarcoma. Unlike conventional treatments that might require daily sessions over several weeks, this approach could significantly reduce treatment time, making it more convenient for patients. Researchers are excited about this method because it has the potential to maintain or even improve effectiveness while minimizing the burden of frequent hospital visits. This could lead to better patient compliance and potentially quicker recovery times.

What evidence suggests that Hypofractionated Radiation Therapy might be an effective treatment for soft tissue sarcoma?

Research has shown that hypofractionated radiation therapy, which participants in this trial will receive, might be as effective as standard treatments for controlling soft tissue sarcomas, cancers in connective tissues. Studies have found this method safe and effective when used before surgery to treat these cancers. The data suggests it provides a good balance of radiation dose with manageable side effects and wound issues. Traditional radiation has been less than 50% successful in controlling cancer locally after two years, but hypofractionated therapy offers promising results. Overall, the evidence suggests this method is a strong option for managing soft tissue sarcomas. ^{1 5 6 7 8}

Who Is on the Research Team?

Jennifer Harper, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with confirmed soft tissue sarcoma in the arms or legs who can consent to treatment, have a performance status allowing daily activities with little or no assistance, and are eligible for surgery. It's aimed at those who may face barriers to standard 5-week radiotherapy due to risks of cancer progression, travel burdens, or financial/work constraints.

Inclusion Criteria

I am willing to participate and have signed the consent form.

My cancer in the arm, leg, or trunk has been confirmed by tissue analysis.

I can care for myself but may not be fully active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive preoperative 5-day Hypofractionated radiotherapy to treat cancer and preserve healthy tissue

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month post-operation visit

6 months

7 visits (in-person)

Long-term follow-up

Participants are monitored for overall survival and relapse-free survival

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview

The study tests Hypofractionated radiation therapy as a preoperative treatment for soft tissue sarcoma. This approach aims to treat the tumor effectively while preserving surrounding healthy tissue and preventing spread, potentially offering a shorter treatment duration than conventional methods.

How Is the Trial Designed?

Group I: Hypofractionated Radiation Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

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 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 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 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]

A survey of 47 sarcoma specialists revealed that local control is the most critical outcome for considering hypofractionated preoperative radiation therapy (RT) as standard care, with 78% willing to accept local control rates of 85% or higher based on phase II data.

Only 17% of providers require randomized phase III evidence to adopt hypofractionated RT, indicating a significant openness to change practice based on emerging data, but there is a need for consensus on acceptable thresholds for complications and toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma. Valle, LF., Bernthal, N., Eilber, FC., 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.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301624029754

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.

3.

thegreenjournal.com

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

Balancing the dose: A meta-analysis of preoperative ...

Moderate hypofractionation shows balanced toxicity and wound complication rates. ... Ultra-hypofractionation has MWC rates below 41 %, but heterogeneous data.

4.

redjournal.org

redjournal.org/article/S0360-3016(23)04998-2/fulltext

Initial Results of a Phase II Trial of Hypofractionated ...

Conventionally fractionated radiation provides modest (< 50%) rates of local control (LC) for STS at 2 years. To our knowledge, no prospective studies to date ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02634710

Hypofractionated Pre-operative Radiation Therapy for Soft ...

Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814022045881

Early outcomes of ultra-hypofractionated preoperative ...

This critical review aims to summarize the relevant published data regarding hypofractionation regimens for preoperative radiation therapy (RT) prior to ...

7.

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.

8.

thelancet.com

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

Hypofractionated, 3-week, preoperative radiotherapy for ...

Moderately hypofractionated preoperative radiotherapy delivered to patients with soft tissue sarcomas was safe and could therefore be a more ...