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}

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 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

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

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] There are limited data regarding the use of hypofractionated radiation therapy (RT) for soft tissue sarcoma. We report early oncologic outcomes and wound complications of patients undergoing preoperative hypofractionated (5 fraction) RT followed by immediate surgical resection.

2. England pubmed.ncbi.nlm.nih.gov

Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [2022] Soft tissue sarcomas (STS) represent a diverse group of rare malignant tumors. Currently, five to six weeks of preoperative radiotherapy (RT) combined with surgery constitute the mainstay of therapy for localized high-grade sarcomas (G2-G3). Growing evidence suggests that shortening preoperative RT courses by hypofractionation neither increases toxicity rates nor impairs oncological outcomes. Instead, shortening RT courses may improve therapy adherence, raise cost-effectiveness, and provide more treatment opportunities for a wider range of patients. Presumed higher rates of adverse effects and worse outcomes are concerns about hypofractionated RT (HFRT) for STS. This systematic review summarizes the current evidence on preoperative HFRT for the treatment of STS and discusses toxicity and oncological outcomes compared to normofractionated RT.

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

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018] The primary treatment of soft tissue sarcomas (STS) is a radical resection of the tumor with adjuvant radiotherapy. Conventional fractionation of preoperative radiotherapy is 50 Gy in fraction of 2 Gy a day. The purpose of the conducted study was to assess the efficacy and safety of hypofractionated radiotherapy in preoperative setting in STS patients.

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

Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. [2022] Standard therapy for localised, resectable high risk soft tissue sarcomas consists of wide excision and radiotherapy over several weeks. This treatment schedule is hardly feasible in geriatric and frail patients. In order not to withhold radiotherapy from these patients, hypofractionated radiotherapy with 25 Gy in 5 fractions was evaluated in a geriatric patient population.

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] Management of adult soft tissue sarcomas entails a multidisciplinary approach with surgery and radiation therapy with or without chemotherapy. The use of preoperative irradiation has been well established, and although conventional fractionation involves daily treatments over the course of 5 weeks, higher doses per fraction may be beneficial due to the radiobiologic profile of sarcoma. In this study we report long-term oncologic outcomes from a single-institution, phase II study evaluating a 5-fraction hypofractionated course of preoperative radiation.

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] To evaluate if application of blood flow restriction (BFR) combined with low-load resistance training (LLRT) would induce significant anterior knee pain (AKP) reduction compared to LLRT alone.

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] Heavy-load strength training (HLT) is generally considered the Gold Standard exercise modality for inducing gains in skeletal muscle strength. However, use of heavy external exercise loads may be contraindicative in frail individuals. Low-load resistance exercise combined with partial blood-flow restriction (LL-BFR exercise) may offer an effective alternative for increasing mechanical muscle strength and size. The aim of this study was to compare the effect of LL-BFR training to HLT on maximal muscle strength gains. Prospero registration-id (CRD42014013382).

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] Blood Flow Restriction Training (BFRT) is a novel strengthening technique utilitarian in many conditions. But there is lack of exploration on this clinical intervention. The training can prove to be a boon in many conditions such as muscle weakness, degenerative among others. It can serve to be an essential treatment in prevention of disuse atrophy occurring on the initial days of bed-rest on post surgical patients and improve circulation. BFRT with aerobic activities can improve cardiovascular fitness and holistically help in rehabilitation. The electronic databases such as PubMed, ScienceDirect, Scopus and Google Scholars were reviewed including the reference lists to retrieve relevant information regarding the topic. The result of the review states that BFRT is a novel strength training program that has not been explored in India but is very effective, less expensive and innovative way of rehabilitation. The utility of BFRT is evident in post-operative disuse atrophy in the initial days of bed-rest. The evidence depict that BFRT is a very effective training modality that can efficiently improve the muscle function, strength and mass.

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] The purpose of this report is to describe the case of a patient with chronic obstructive pulmonary disease (COPD) who was load compromised and being referred for outpatient pulmonary rehabilitation. Low-load blood flow restriction strength training (LL-BFRT) was applied to prepare for and increase tolerability of subsequently applied high-load strength training.

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

Acute effects of resistance exercise with blood flow restriction on cardiovascular response: a meta-analysis. [2022] Aim: To compare the acute effects of low-load resistance training associated with blood flow restriction (LLRT-BFR) with low-load resistance training (LLRT) and high-load resistance training (HLRT) on cardiovascular outcomes in healthy individuals. Methods: This review was registered and the studies were selected using seven databases. Randomized controlled clinical trials were included that evaluated LLRT-BFR compared with LLRT and HLRT in young individuals for the cardiovascular outcomes. Results: 19 studies were included. In the comparison of LLRT-BFR with HLRT, there were significant differences for cardiac output and heart rate - with reduced values and in favor of LLRT-BFR. Conclusion: There are no greater acute effects of the addition of blood flow restriction, with the exception of the reduction in cardiac output and heart rate for LLRT-BFR compared with HLRT.