GRID Therapy for Extremity Soft Tissue Sarcoma

Last updated: March 14, 2025
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoma

Treatment

GRID therapy

Clinical Study ID

NCT06073067
LCCC2250-DCT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  1. Written informed consent was obtained to participate in the study and HIPAAauthorization for the release of personal health information. Subjects are willingand able to comply with study procedures based on the judgment of the investigator.

  2. Age ≥ 18 years at the time of consent.

  3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (KarnofskyPerformance Status equivalent of 50 - 100).

  4. Histological or cytological evidence/confirmation of extremity soft tissue sarcomaas determined by core-needle biopsy or excision biopsy. If the diagnostic tissue isnot available or sufficient to perform correlative studies, must be willing toprovide the mandatory pre-treatment core-needle biopsy. In some cases of extremitySTS, subjects undergo an attempted surgical resection for a presumed benigncondition and the specimen reveals malignancy. Such subjects are allowed so long asa complete, oncologic, resection was not performed/attempted and there is ≥ 5 cm ofthe remaining primary tumor.

Exclusion

Exclusion Criteria:

Subjects meeting any of the exclusion criteria listed below at baseline will be excluded from the study.

  1. Subjects who have received prior radiotherapy to the tumor site.

  2. Subjects who have undergone complete tumor resection of the primary tumor or whohave developed tumor recurrence after resection.

  3. History of serious or non-healing wound, ulcer, or bone fracture in the treatmentlimb within the last 5 years.

  4. History of clinically significant lymphedema in the treated limb.

  5. History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (anytype), or other collagen vascular disease that may pose a relative contraindication,due to increased risk of skin or soft tissue toxicity, with radiation.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: GRID therapy
Phase:
Study Start date:
November 09, 2023
Estimated Completion Date:
August 15, 2026

Connect with a study center

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

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.