GRID Therapy for Extremity Soft Tissue Sarcoma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06073067
Status
Recruiting
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Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GRID therapy — RADIATION
    GRID therapy delivers a high dose of radiation to small areas of tumor interleaved with areas that intentionally receive a low dose

Study Details

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.

Key Dates

Start date
Nov 9, 2023
Status verified
Oct 2025
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fractionated grid radiation therapy
    Subjects with resectable extremity soft tissue sarcoma received neoadjuvant grid radiation therapy (GRID), followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.

Primary Outcome Measure

Grade 2 or higher post-operative wound complications after GRID-3 months [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel HillNorth Carolina27599
Erin Jennings
[email protected]
984-974-8441
Theodore K Yanagihara, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill, Department of Radiation Oncology· Chapel Hill, NC

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