Short-Course Radiotherapy + Surgery for Soft Tissue Sarcoma

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt-Ingram Cancer Center

Disqualifiers: Prior radiation, Pregnancy, Collagen vascular disease

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Short-Course Radiotherapy + Surgery for Soft Tissue Sarcoma?

Research shows that using shorter courses of radiotherapy before surgery for soft tissue sarcoma can be effective without increasing side effects. This approach may improve treatment adherence and provide more options for patients, especially those who are older or frail. ^{1 2 3 4 5}

Is short-course radiotherapy safe for soft tissue sarcoma patients?

Research shows that using short-course radiotherapy (hypofractionated radiotherapy) before surgery for soft tissue sarcoma is generally safe and does not increase the risk of side effects compared to traditional longer courses. It may also improve treatment adherence and be more cost-effective, especially for older or frail patients. ^{1 2 4 5 6}

How is the treatment of hypofractionated radiotherapy for soft tissue sarcoma different from other treatments?

Hypofractionated radiotherapy for soft tissue sarcoma is unique because it delivers higher doses of radiation in fewer sessions, typically over a shorter period, compared to the conventional approach that spreads out smaller doses over several weeks. This can be particularly beneficial for older or frail patients who may struggle with longer treatment schedules, and it may improve treatment adherence and cost-effectiveness without increasing side effects. ^{1 2 4 5 6}

What is the purpose of this trial?

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Research Team

Eric Shinohara, MD

Principal Investigator

Vanderbilt Medical Center

Eligibility Criteria

This trial is for individuals with a confirmed diagnosis of soft tissue sarcoma located in the limbs, pelvis, chest wall or non-retroperitoneal abdominal wall. Participants should be able to perform daily activities (ECOG status 0-2) and must be fit for radiation treatment and surgery. It's not open to those who've had prior radiation in the same area, have metastatic disease, are pregnant, will receive neoadjuvant chemotherapy, or have certain diseases that increase radiation side effects.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

My cancer is a type of soft tissue sarcoma located in my limbs, pelvis, chest wall, or abdominal wall.

I am able to undergo radiation treatment and surgery.

Exclusion Criteria

I have had radiation treatment on the same area before.

I am scheduled for chemotherapy before surgery.

I have a genetic condition that increases my risk of side effects from radiation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo neoadjuvant hypofractionated radiotherapy (HRT) for either 5 or 15 fractions

1-3 weeks

Surgery

Participants undergo surgical resection following completion of radiotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Minimum of 2 years

Treatment Details

Interventions

• Hypofractionated Radiotherapy

Trial Overview The study is testing two shorter courses of hypofractionated radiotherapy (5 or 15 days) followed by surgical removal of the tumor in patients with soft tissue sarcoma. This approach is compared against the traditional longer course (5 weeks) to see if it can reduce treatment time without increasing wound complications or chances of cancer returning.

Participant Groups

Group I: Group II (MH HRT) Experimental Treatment 3 Interventions

Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Group II: Group I (UH HRT) Experimental Treatment 3 Interventions

Patients undergo HRT daily for a total of 5 fractions followed by surgery.

Hypofractionated Radiotherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

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]

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]

Neoadjuvant ultra-hypofractionation radiotherapy for soft tissue sarcoma shows a low wound complication rate of 30%, indicating it is a safe treatment option.

The treatment also demonstrates high efficacy with an 87% R0 resection rate and a 96% local control rate over two years, suggesting it effectively prepares patients for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies. Kao, YS.[2023]

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]

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]

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. Poland pubmed.ncbi.nlm.nih.gov

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

3. France pubmed.ncbi.nlm.nih.gov

Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

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]