What side effects are associated with this type of intervention?

Common treatments for Soft Tissue Sarcoma (STS) include stereotactic radiosurgery (SRS) like CyberKnife, traditional radiation therapy, and chemotherapy. SRS, which precisely targets tumors with high-dose radiation, can cause side effects such as skin irritation, fatigue, and localized pain. Traditional radiation therapy may lead to skin changes, fatigue, and long-term risks like secondary malignancies and fibrosis. Chemotherapy, often used in conjunction with radiation, can result in nausea, vomiting, hair loss, cardiotoxicity, renal damage, and increased risk of infections. Each treatment's side effects vary based on individual patient factors and specific treatment protocols.

What prior FDA approvals exist?

The FDA has approved several treatments for soft tissue sarcoma, including targeted therapies and chemotherapeutic agents. Notably, regorafenib, a multitargeted kinase inhibitor, has shown efficacy in nonadipocytic soft tissue sarcomas. Additionally, pazopanib is approved for advanced sarcomas other than liposarcoma or GIST. While CyberKnife, a form of stereotactic radiosurgery, is being studied for its precise radiation targeting capabilities, traditional radiation therapy remains a cornerstone in the management of soft tissue sarcomas, often used in conjunction with surgery and chemotherapy.

What other types of research exist?

Promising novel alternatives to CyberKnife for soft tissue sarcoma patients include the use of multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib. Additionally, neoadjuvant chemotherapy, potentially combined with preoperative radiation therapy, and the use of TRK inhibitors like larotrectinib for TRK fusion-positive sarcomas are emerging as effective treatment options.

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Radiation Therapy

Stereotactic Radiosurgery for Soft Tissue Sarcoma

N/A

Waitlist Available

Research Sponsored by The Cooper Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 1: Soft tissue sarcoma (of any histology subtype) in patients that are planned to have pre-operative radiation followed by surgical resection. Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip). Patient performance status and co-morbid conditions to allow for surgical resection

Cohort 2: Soft tissue sarcoma (of any histologic subtype) post-resection with no further plans for additional surgery. Patients must have high risk feature requiring post-operative radiation which can include Large tumor (> 5 cm), High grade, Previous unplanned, non-oncologic surgery, Close margins. Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CyberKnife, a precise radiation therapy, on patients with certain types of soft tissue tumors. The goal is to see if it can be more effective and less toxic than conventional treatments. CyberKnife uses focused radiation to target tumors while protecting healthy tissue. CyberKnife has been used effectively in treating various cancers, including tumors in the abdomen, with high response rates and minimal side effects.

Who is the study for?

Adults over 18 with soft tissue sarcoma, who agree to use contraception during treatment. It includes those planning pre-op radiation and surgery, post-surgery patients needing additional radiation due to high-risk features like large or high-grade tumors, and patients whose sarcomas can't be surgically removed. Not for retroperitoneal sarcoma cases.

What is being tested?

The trial is testing CyberKnife radiosurgery on soft tissue sarcomas in different situations: before surgery, after surgery with risk factors for recurrence, and when the tumor cannot be operated on. The goal is to see how well it works in these scenarios.

What are the potential side effects?

While not specified here, typical side effects of radiosurgery like CyberKnife may include fatigue, skin reactions at the treatment site, swelling or bruising around the treated area, nausea or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have soft tissue sarcoma in my arm or leg and am set for surgery after radiation.

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I have a high-risk soft tissue sarcoma, not planning more surgeries, and need radiation.

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My cancer has spread to other parts of my body.

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My soft tissue sarcoma cannot be removed by surgery and is located in my arms or legs.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: C: Non-resectableExperimental Treatment1 Intervention

Radiation- CyberKnife: 50 Gy over 5 fractions

Group II: B: Post-operativeExperimental Treatment1 Intervention

Radiation- CyberKnife: 40 Gy over 5 fractions

Group III: A: pre-operativeExperimental Treatment1 Intervention

Radiation- CyberKnife: 35-40 Gy over 5 fractions Surgery: Surgical resection of sarcoma

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CyberKnife

2009

Completed Phase 2

~150

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Soft Tissue Sarcoma (STS) include surgery, radiation therapy, and chemotherapy. Surgery aims to remove the tumor with clear margins to prevent recurrence. Radiation therapy, such as CyberKnife (Stereotactic Radiosurgery), uses precise radiation targeting to destroy cancer cells while sparing surrounding healthy tissue, which is crucial for minimizing side effects and preserving function, especially in complex anatomical areas. Chemotherapy works by using drugs to kill rapidly dividing cancer cells or inhibit their growth. These treatments are essential for STS patients as they offer a multi-faceted approach to manage and potentially cure the disease, improve survival rates, and maintain quality of life.

The Role of Stereotactic Radiotherapy in the Management of Melanoma, A Retrospective Single Institute Preliminary Study of 30 Patients.[Stereotactic radiotherapy for spinal meningiomas and neurinomas].