Short-course Radiotherapy for Soft Tissue Sarcoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical University of South Carolina

Disqualifiers: Metastatic disease, Prior radiation, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surgery. Secondary objectives include evaluation of the rates of favorable pathologic response, major wound complications, local control, acute toxicity, and 1-year late toxicity will be assessed. Exploratory objectives include evaluation of the impact of preoperative 5-day HFRT on access to care, the socio-demographic profile of the trial participants will be compared to that of extremity STS patients seen within Hollings Cancer Center (HCC) and recommended preoperative conventional fractionation radiotherapy (CFRT) in the 3 years prior to the study opening. The retention rate for radiotherapy at HCC in patients meeting trial criteria during the prior 3 years will be compared with the retention rate for radiotherapy during the study period. An exploratory analysis will measure serum SFRP2 pre- and post- radiotherapy to assess changes in response to preoperative 5-day HFRT. Changes in serum SFRP2 will be evaluated for association with a favorable pathologic response to determine the potential of serum SFRP2 as a predictive biomarker. Patient satisfaction with the decision to participate in a trial of preoperative 5-day HFRT will be assessed.

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

Research shows that using a shorter course of hypofractionated radiation therapy (fewer, larger doses) before surgery for soft tissue sarcoma does not increase side effects or worsen cancer outcomes compared to the traditional longer course. This approach may also improve treatment adherence and be more cost-effective, especially for older or frail patients. ^{1 2 3 4 5}

Is hypofractionated radiotherapy safe for humans?

Research shows that hypofractionated radiotherapy (shorter, higher-dose radiation treatments) for soft tissue sarcomas does not increase the risk of side effects compared to traditional longer courses. It may even improve treatment adherence and be more cost-effective, making it a generally safe option for patients. ^{1 2 3 4 5}

How is Hypofractionated Radiation Therapy (HFRT) different from other treatments for soft tissue sarcoma?

Hypofractionated Radiation Therapy (HFRT) is unique because it delivers higher doses of radiation in fewer sessions compared to traditional radiation therapy, potentially reducing the overall treatment time and making it more convenient for patients. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Hypofractionated Radiation Therapy (Radiation)

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.

Participant Groups

Group I: Hypofractionated Radiation Therapy Experimental Treatment 1 Intervention

Hypofractionated Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Patients Recruited

7,408,000+

Findings from Research

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 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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

6. England 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. [2018]

7. Denmark pubmed.ncbi.nlm.nih.gov

Effect of blood-flow restricted vs heavy-load strength training on muscle strength: Systematic review and meta-analysis. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training-An Overview and Implication in New Generation Physical Therapy: A Narrative Review. [2022]

9. United States 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Acute effects of resistance exercise with blood flow restriction on cardiovascular response: a meta-analysis. [2022]