Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Overseen By Beverly Guadagnolo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Previous radiation, Metastases, Pregnancy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

122 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Hypofractionated Radiation Therapy for Soft Tissue Sarcoma?

Research suggests that hypofractionated radiation therapy (shorter, higher-dose treatments) for soft tissue sarcoma can be as effective as traditional longer courses, without increasing side effects. It may also improve treatment adherence and be more cost-effective, especially for older or frail patients. ^{1 2 3 4 5}

Is hypofractionated radiation therapy safe for humans?

Research suggests that hypofractionated radiation therapy (shorter, higher-dose treatments) for soft tissue sarcomas does not increase the risk of side effects compared to traditional radiation therapy. It may even improve treatment adherence and be more cost-effective, making it a generally safe option for patients. ^{1 2 4 5 6}

How is Hypofractionated Radiation Therapy 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, which can make the treatment process shorter and more convenient for patients. ^{7 8 9 10 11}

Research Team

Beverly A. Guadagnolo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with localized soft tissue sarcoma in limbs or superficial trunk, who can undergo surgery and have no distant cancer spread. They must be able to follow up, use contraception if capable of childbearing, and have a life expectancy over 6 months. Those previously treated with radiation at the same site or pregnant women are excluded.

Inclusion Criteria

I had a biopsy that might not have removed all cancer, but further surgery is advised.

I can take care of myself but can't do heavy physical work.

My tumor is in the soft tissue of my limbs or upper body.

Exclusion Criteria

I've had radiation therapy before on the same area where my sarcoma is now.

I am currently pregnant.

My cancer has spread to lymph nodes or other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Every 3-4 months for 2 years, every 6 months for 3 years, then annually

Treatment Details

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests a shorter course of high-dose radiation therapy before surgery compared to traditional longer courses. It aims to see if this approach reduces tumor cells effectively while causing fewer side effects and complications during wound healing.

Participant Groups

Group I: Treatment (hypofractionated RT) Experimental Treatment 3 Interventions

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

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]

Hypofractionated radiation therapy (HFRT) was effective in providing durable local control and symptom relief for 73 patients with sarcoma, achieving a 1-year local control rate of 73% and a 1-year disease-specific survival rate of 59%.

HFRT was particularly beneficial for patients with oligometastatic (100% survival) and oligoprogressive disease (73% survival), with minimal acute toxicities (49% grade 1-2) and no severe late toxicities, making it a safe option for palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiation Therapy for Unresectable or Metastatic Sarcoma Lesions. Boyce-Fappiano, D., Damron, EP., Farooqi, A., 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]

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]

A review of 21 randomized controlled trials found that Blood Flow Restriction Therapy (BFRT) combined with exercise did not significantly improve athletic performance, muscle strength, or hypertrophy compared to exercise alone.

Both immediate and long-term effects of BFRT on sprint and jump performance, as well as muscle strength and hypertrophy, showed no significant differences, suggesting that BFRT may not provide additional benefits over traditional exercise methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood flow restriction therapy with exercise are no better than exercise alone in improving athletic performance, muscle strength, and hypertrophy: a systematic review and meta-analysis. Khurana, D., Dutta, N., Malik, S., et al.[2023]

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]

Blood flow restriction therapy (BFRT) uses a pneumatic cuff to restrict blood flow, creating a hypoxic environment that promotes muscle growth and strength gains, making it particularly beneficial for postoperative rehabilitation.

BFRT allows for effective low-load resistance training that achieves similar strength and hypertrophy results as higher-load training, but with less muscle swelling and pain, making it a safer option for those recovering from surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. Watson, R., Sullivan, B., Stone, A., et al.[2023]

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

Hypofractionated Radiation Therapy for Unresectable or Metastatic Sarcoma Lesions. [2022]

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

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

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

Blood flow restriction therapy with exercise are no better than exercise alone in improving athletic performance, muscle strength, and hypertrophy: a systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Assessment of factors associated with measurability of fractional flow reserve derived from coronary computed tomography angiography in type 2 diabetic patients with intermediate coronary artery stenosis. [2020]

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

Fractional flow reserve derived from coronary computed tomography angiography: diagnostic performance in hypertensive and diabetic patients. [2022]

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

Blood Flow Restriction Therapy: An Evidence-Based Approach to Postoperative Rehabilitation. [2023]