Clinical trial NCT06073067: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Keywords: extremity
radiation
GRID
surgery
preoperative
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Radiation Oncology Institute
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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: 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 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.
2. Age ≥ 18 years at the time of consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).
4. 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.

1. Subjects who have received prior radiotherapy to the tumor site.
2. Subjects who have undergone complete tumor resection of the primary tumor or who have developed tumor recurrence after resection.
3. History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb 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 (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.

Primary outcomes:
measure: Grade 2 or higher post-operative wound complications after GRID-3 months
timeFrame: 3 months
Secondary outcomes:
measure: The tumor specimen of the surgery
timeFrame: At the time of surgery (Approximately 17th week)
measure: Grade 2 or higher post-operative wound complications after GRID-6 months
timeFrame: 3 months to 6 months
measure: Long Term Safety
timeFrame: 6 months after completrion of radiotherapy
measure: The comparative effect of GRID
timeFrame: At the time of surgery (Approximately 17th week after completion of radiotherapy)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Theodore K Yanagihara, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: