GRID Therapy for Extremity Soft Tissue Sarcoma

Official title

Safety, Efficacy, and Mechanism of Pre-operative Spatially Fractionated GRID Radiation Therapy in Patients With Extremity Soft Tissue Sarcoma: A Pilot Study

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (4)

• The tumor specimen of the surgery [Time frame: At the time of surgery (Approximately 17th week)]
• Grade 2 or higher post-operative wound complications after GRID-6 months [Time frame: 3 months to 6 months]
• Long Term Safety [Time frame: 6 months after completrion of radiotherapy]
• The comparative effect of GRID [Time frame: At the time of surgery (Approximately 17th week after completion of radiotherapy)]

Eligibility criteria

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

Inclusion criteria

• Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
• Age ≥ 18 years at the time of consent.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).
• Histological or cytological evidence/confirmation of extremity soft tissue sarcoma as determined by core-needle biopsy or excision biopsy. If the diagnostic tissue is not available or sufficient to perform correlative studies, must be willing to provide the mandatory pre-treatment core-needle biopsy. In some cases of extremity STS, subjects undergo an attempted surgical resection for a presumed benign condition and the specimen reveals malignancy. Such subjects are allowed so long as a complete, oncologic, resection was not performed/attempted and there is ≥ 5 cm of the remaining primary tumor.

Exclusion criteria

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

• Subjects who have received prior radiotherapy to the tumor site.
• Subjects who have undergone complete tumor resection of the primary tumor or who have developed tumor recurrence after resection.
• History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb within the last 5 years.
• History of clinically significant lymphedema in the treated limb.
• History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (any type), or other collagen vascular disease that may pose a relative contraindication, due to increased risk of skin or soft tissue toxicity, with radiation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

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

Identifiers

NCT: NCT06073067 · LCCC2250-DCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗