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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 5 years

Awards & highlights

Study Summary

This trial is testing CyberKnife as a treatment for soft tissue sarcomas (a type of cancer).

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.Check my eligibility

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.See study design

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 ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Progression Free Survival

Secondary outcome measures

change in tumor burden by RECIST 1.1 response assessment

overall survival

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

~60

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor

76 Previous Clinical Trials

33,113 Total Patients Enrolled

Media Library

CyberKnife (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02706171 — N/A

Soft Tissue Sarcoma Research Study Groups: A: pre-operative, B: Post-operative, C: Non-resectable

Soft Tissue Sarcoma Clinical Trial 2023: CyberKnife Highlights & Side Effects. Trial Name: NCT02706171 — N/A

CyberKnife (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02706171 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research project still open at this time?

"This research endeavour is not actively seeking participants at the moment, as documented on clinicaltrials.gov. Originally posted June 1st 2015 and last updated March 7th 2016. However, 443 other trials are currently accepting patients to join their studies."

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