Short-course Radiotherapy for Soft Tissue Sarcoma

Overseen By Jasmin M Brooks

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Metastatic disease, Prior radiation, others

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: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering hypofractionated radiation therapy for soft tissue sarcoma, a cancer that forms in soft tissues like muscles or fat. The trial aims to determine if a short, 5-day radiation treatment before surgery is effective and safe for those eligible for cancer removal surgery. The study will evaluate the treatment's effectiveness, side effects, and patient satisfaction. Individuals with soft tissue sarcoma in their arms, legs, or trunk who are candidates for surgery might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options.

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, if you are planning to undergo chemotherapy, you may not be eligible for this trial.

What prior data suggests that this radiotherapy technique is safe for soft tissue sarcoma patients?

Research has shown that hypofractionated radiotherapy, a type of radiation treatment given in fewer but stronger doses, is generally safe for patients with soft tissue sarcomas. Studies have found that this treatment can control the cancer and cause side effects similar to standard radiation therapy, which usually takes longer.

One study found that administering this type of radiation over five days before surgery is as safe and manageable as the longer, traditional method. Patients did not experience unexpected side effects or difficulties with the treatment.

Overall, evidence supports hypofractionated radiotherapy as a safe option for those with soft tissue sarcomas, with side effects similar to those of standard treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hypofractionated radiation therapy for soft tissue sarcoma because it offers a faster and potentially more convenient treatment option compared to the standard, longer courses of radiotherapy. Traditional treatments for this condition typically involve multiple weeks of daily radiation sessions, which can be taxing for patients. Hypofractionated radiation therapy, on the other hand, delivers higher doses of radiation over a shorter period, potentially leading to similar or improved outcomes with fewer hospital visits. This approach not only aims to maintain efficacy but also enhances patient comfort and quality of life by reducing the overall treatment time.

What evidence suggests that hypofractionated radiation therapy is effective for soft tissue sarcoma?

Research shows that hypofractionated radiotherapy (HFRT), which participants in this trial will receive, can effectively treat soft tissue sarcomas (STS). Studies have found that HFRT provides similar cancer control and side effects compared to the usual 5-week radiation therapy. In some cases, HFRT offers even better cancer control without increasing side effects. Previous trials demonstrated that HFRT is a safe and effective pre-surgery treatment for STS. This treatment delivers high doses of radiation in a shorter time, potentially protecting healthy tissue while targeting the tumor. These findings suggest that HFRT could be a promising option for patients with STS. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with stage I-III soft tissue sarcoma in limbs or trunk, fit for surgery and radiotherapy. Excluded if they have cancer spread to distant parts of the body, previous radiation in the same area, are treating another cancer simultaneously, or plan to use chemotherapy before/after surgery.

Inclusion Criteria

My cancer is in an early to mid-stage and is located in my limbs or torso.

I am over 18 years old.

I am considered a good candidate for a type of surgery that removes only the cancerous area.

Exclusion Criteria

I am scheduled for chemotherapy before or after surgery.

I am not receiving treatment for another cancer.

I have had radiation therapy in the area to be treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Hypofractionated Radiotherapy

Participants receive a 5-day hypofractionated radiotherapy regimen for extremity soft tissue sarcoma

1 week

5 visits (in-person)

Surgery

Participants undergo limb-preserving surgery following radiotherapy

1 day

Follow-up

Participants are monitored for safety, effectiveness, and wound complications after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview

The trial tests a short-term (5-day) pre-surgery radiotherapy approach for soft tissue sarcoma patients. It aims to see how well this method works compared to traditional longer treatments by looking at tumor response, healing complications, control of local tumor growth and side effects within one year.

How Is the Trial Designed?

Group I: Hypofractionated Radiation Therapy Experimental Treatment 1 Intervention

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?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

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]

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]

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 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]

Combining blood flow restriction (BFR) with low-load resistance training (LLRT) significantly reduced anterior knee pain (AKP) immediately after exercise in a study of 40 males, while LLRT alone did not show similar results.

The LLRT-BFR group maintained pain reduction after a physiotherapy session, suggesting that this method could be an effective preconditioning strategy for rehabilitation of AKP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low load resistance training with blood flow restriction decreases anterior knee pain more than resistance training alone. A pilot randomised controlled trial. Korakakis, V., Whiteley, R., Giakas, G.[2018]

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]

Blood Flow Restriction Training (BFRT) is an effective and innovative rehabilitation technique that can prevent muscle atrophy in post-surgical patients during initial bed rest, improving muscle function, strength, and mass.

BFRT, when combined with aerobic activities, not only enhances muscle strength but also improves cardiovascular fitness, making it a versatile treatment option for various conditions related to muscle weakness and degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training-An Overview and Implication in New Generation Physical Therapy: A Narrative Review. Saraf, A., Goyal, M., Goyal, K.[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]

Low-load resistance exercise combined with partial blood-flow restriction (LL-BFR) is as effective as heavy-load strength training (HLT) for increasing maximal muscle strength, based on a meta-analysis of 16 studies with 310 participants.

This finding suggests that LL-BFR training can be a safer alternative for individuals who may not tolerate heavy weights, such as frail or older adults, while still achieving similar strength gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of blood-flow restricted vs heavy-load strength training on muscle strength: Systematic review and meta-analysis. Grønfeldt, BM., Lindberg Nielsen, J., Mieritz, RM., et al.[2022]

A 62-year-old woman with COPD showed significant improvements in lower limb strength (up to 521% for knee extensors) and functional exercise capacity after undergoing low-load blood flow restriction strength training (LL-BFRT) followed by high-load strength training, indicating that LL-BFRT can effectively prepare patients for more intense rehabilitation.

The patient experienced no adverse events during the training, suggesting that LL-BFRT is a safe and well-tolerated intervention that can enhance the effectiveness of pulmonary rehabilitation for individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Flow-Restricted Strength Training Combined With High-Load Strength and Endurance Training in Pulmonary Rehabilitation for COPD: A Case Report. Kohlbrenner, D., Aregger, C., Osswald, M., et al.[2021]

Citations

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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 ...

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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 ...

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sciencedirect.com

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

Hypofractionated accelerated radiation dose-painting ...

HARD regimen significantly improves LC for unresectable STS without a significant increase in toxicity, when compared to a standard fractionated approach.

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pubmed.ncbi.nlm.nih.gov

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Hypofractionated Preoperative Radiation Therapy for Soft ...

Conclusions: There is a growing body of evidence supporting hypofractionation as safe and effective in the preoperative treatment of STS. This ...

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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 ...

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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 ...

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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.