Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06073067

GRID Therapy for Extremity Soft Tissue Sarcoma

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-10-20

20

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

R

Radiation Oncology Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications. GRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.

CONDITIONS

Official Title

GRID Therapy for Extremity Soft Tissue Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent and HIPAA authorization
  • Age 18 years or older at consent
  • ECOG Performance Status of 0 to 2 (or Karnofsky score 50 to 100)
  • Confirmed diagnosis of extremity soft tissue sarcoma by biopsy
  • If prior surgery for presumed benign condition, at least 5 cm of tumor remains without complete resection
Not Eligible

You will not qualify if you...

  • Prior radiotherapy to the tumor site
  • Complete tumor removal or tumor recurrence after surgery
  • Serious or non-healing wound, ulcer, or bone fracture in the treatment limb within 5 years
  • Clinically significant lymphedema in the treated limb
  • History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome, or other collagen vascular disease with increased radiation risk

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

E

Erin Jennings

CONTACT

C

Claire Kowalczyk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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