5-Day Preoperative Radiotherapy for Soft Tissue Sarcoma

Overseen By Camellia Djebroun

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Chemotherapy, Targeted therapy, Immunotherapy

Disqualifiers: 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

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

Compensation: Varies

Number of Visits: 5

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, shorter method to deliver preoperative radiation treatment for individuals with soft tissue sarcoma, a cancer that can occur in the limbs, trunk, or abdomen. Instead of the usual 25-day radiation course, the trial tests whether delivering radiation over just 5 days is safe and effective. This approach could benefit those diagnosed with soft tissue sarcoma who have been advised to receive radiation and surgery as part of their standard treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other anti-cancer investigational agents or have planned concurrent chemotherapy, targeted therapy, or immunotherapy during the radiation treatment period.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a 5-day radiation treatment before surgery for soft tissue sarcoma is generally well-tolerated. In one study, patients who received this shorter treatment, consisting of 30 Gy over five days, experienced good safety results. The rates of wound problems and serious side effects remained low even after two years. Another analysis suggested that this shorter treatment is as safe as the traditional longer one, with acceptable rates of complications. This evidence indicates that the shorter radiation treatment is a safe option for patients with soft tissue sarcoma. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for soft tissue sarcoma?

Researchers are excited about the 5-Day Preoperative Radiotherapy for soft tissue sarcoma because it offers a faster, potentially more convenient treatment option. Unlike the standard radiotherapy protocols that typically extend over several weeks, this approach delivers external beam radiotherapy in just five days with a total dose of 30 Gy. This accelerated schedule could reduce the time patients spend undergoing treatment and the associated disruptions to their lives while still effectively targeting the tumor. Additionally, a shorter treatment duration may decrease healthcare costs and improve patient compliance.

What evidence suggests that 5-day preoperative radiation might be an effective treatment for soft tissue sarcoma?

Research has shown that a 5-day course of preoperative radiotherapy can effectively treat soft tissue sarcoma. In this trial, participants will receive external beam radiotherapy, with a total of 30 Gy delivered over five daily fractions. This approach helps prevent cancer recurrence in the treated area and facilitates successful tumor removal. Most patients in previous studies received a similar total radiation dose, significantly shorter than the usual 25-day treatment. The shorter treatment time has controlled cancer just as effectively, with acceptable side effect levels. However, some studies have noted a slightly higher risk of wound healing problems. ^{1 2 4 5 6}

Who Is on the Research Team?

Anusha Kalbasi

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed soft tissue sarcoma in limbs, trunk, or retroperitoneum. Participants must have a life expectancy of at least 6 months and be fit enough for standard preoperative radiation and surgery. Women able to bear children need a negative pregnancy test. Those who've had prior radiation in the area or plan to use other cancer treatments like chemo alongside can't join.

Inclusion Criteria

My cancer is a type of sarcoma found in my limbs, trunk, or behind the abdomen.

I have been recommended radiation and surgery before other treatments.

I can take care of myself and perform daily activities.

Exclusion Criteria

I have had radiation therapy on the area that needs treatment now.

Pregnancy

You are currently using other experimental cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive an abbreviated course of preoperative radiation, given over five days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

120 days

Long-term follow-up

Participants are monitored for local recurrence, including in-field, borderline, and out-field recurrences

5 years

What Are the Treatments Tested in This Trial?

Interventions

• 5-Day Preoperative Radiation

Trial Overview The study tests the safety and effectiveness of a short, 5-day course of preoperative external beam radiotherapy for soft tissue sarcoma patients compared to the usual longer treatment that takes about 25 days.

How Is the Trial Designed?

Group I: External beam radiotherapy Experimental Treatment 1 Intervention

Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.

5-Day Preoperative Radiation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Radiation Therapy for:

• Soft tissue sarcoma of the extremity
• Soft tissue sarcoma of the trunk
• Soft tissue sarcoma of the retroperitoneum

Approved in European Union as Radiation Therapy for:

• Soft tissue sarcoma of the extremity
• Soft tissue sarcoma of the trunk
• Soft tissue sarcoma of the retroperitoneum

Approved in Canada as Radiation Therapy for:

• Soft tissue sarcoma of the extremity
• Soft tissue sarcoma of the trunk
• Soft tissue sarcoma of the retroperitoneum

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A phase 2 trial involving 120 patients with non-metastatic soft tissue sarcomas showed that a shorter, moderately hypofractionated preoperative radiotherapy regimen (42.75 Gy in 15 fractions) resulted in a major wound complication rate of 31%, which is comparable to the historical rate of 35% for standard treatment.

The study found no significant acute radiation toxicity (grade 3 or worse) during or shortly after treatment, indicating that this hypofractionated approach is safe and may offer a more convenient alternative to traditional radiotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. Guadagnolo, BA., Bassett, RL., Mitra, D., et al.[2023]

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 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 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]

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]

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]

Citations

1. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89829-2/abstract

Meta-analysis of 5-day preoperative radiotherapy for soft ... 5-day RT preoperative courses in sarcomas have acceptable complication rates, although some studies show a higher wound complication rate.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7718495/

Early Outcomes of Preoperative 5-Fraction Radiation ... The majority of the patients received a total radiation dose of 30 Gy in 5 fractions (range, 27.5-40 Gy) on consecutive days. All patients were planned with ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-02555

5-Day Hypofractionated Radiotherapy before Surgery for ... This phase II trial tests the safety, side effects, and effectiveness of 5-day hypofractionated radiotherapy (HFRT) prior to surgery (preoperative)

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814023898292

Meta-analysis of 5-day preoperative radiotherapy for soft ... A 5-day course of preoperative RT results in high LC and favorable R0 margins, with acceptable complication rates in most studies.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05776667

Feasibility Trial of Preoperative 5-Day Hypofractionated ... This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7189949/

A Phase 2 Trial of Five-Day Neoadjuvant Radiation ... A shorter five-day neoadjuvant RT regimen results in favorable rates of wound complications and grade ≥2 toxicity after two years follow-up. Five-day RT ...