5-Day Preoperative Radiotherapy for Soft Tissue Sarcoma

Overseen By Jillian Skerchak

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.

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.

What data supports the effectiveness of the 5-Day Preoperative Radiotherapy treatment for soft tissue sarcoma?

Research shows that using a shorter, 5-day preoperative radiotherapy schedule for soft tissue sarcoma is effective and does not increase side effects compared to the traditional 5-week schedule. This approach may improve patient adherence and reduce costs while maintaining similar cancer control outcomes. ^{1 2 3 4 5}

Is 5-day preoperative radiotherapy for soft tissue sarcoma safe?

Research suggests that 5-day preoperative radiotherapy, also known as hypofractionated radiation therapy, does not increase the risk of side effects compared to the traditional longer course. It may actually improve treatment adherence and be more cost-effective, with similar safety outcomes. ^{1 2 3 4 6}

How is 5-Day Preoperative Radiotherapy different from other treatments for soft tissue sarcoma?

5-Day Preoperative Radiotherapy is unique because it uses a shorter, more intense schedule of radiation over just five days instead of the usual five to six weeks. This approach, known as hypofractionated radiation therapy, aims to be more convenient for patients and may improve treatment adherence without increasing side effects. ^{1 2 3 4 5}

Research Team

Anusha Kalbasi

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

References

1. 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]

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. England 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. [2023]

5. France pubmed.ncbi.nlm.nih.gov

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

6. 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]