Status:
RECRUITING
GRID Therapy for Extremity Soft Tissue Sarcoma
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Radiation Oncology Institute
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06073067
Start Date
November 9 2023
End Date
August 15 2026
Last Update
October 20 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599