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

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.

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.

What data supports the effectiveness of the treatment Hypofractionated Radiation Therapy for soft tissue sarcoma?

Research suggests that hypofractionated radiation therapy, which involves fewer but higher doses of radiation, may be effective for soft tissue sarcomas without increasing side effects. It can improve treatment adherence and cost-effectiveness, making it a viable option for more patients, including those who are older or frail. ^{1 2 3 4 5}

Is hypofractionated radiotherapy safe for humans?

Research shows that hypofractionated radiotherapy, which involves giving higher doses of radiation over a shorter period, does not increase the risk of side effects compared to traditional methods. It is considered safe and may even improve treatment adherence and cost-effectiveness for soft tissue sarcoma patients. ^{1 2 5 6 7}

How is hypofractionated radiation therapy different from other treatments for soft tissue sarcoma?

Hypofractionated radiation therapy for soft tissue sarcoma is unique because it involves delivering a higher dose of radiation in fewer sessions, typically over a shorter period, compared to the traditional approach. This can improve treatment adherence, reduce costs, and make it more accessible for patients who may struggle with longer treatment schedules, such as the elderly or frail. ^{1 2 4 5 7}

Research Team

Jennifer Harper, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for non-metastatic bone and soft tissue sarcomas. [2019]

3. Egypt pubmed.ncbi.nlm.nih.gov

Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018]