Study Details

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

This study is for people with soft tissue sarcoma who are receiving standard radiation therapy (XRT) followed by surgery. Increasing XRT doses before surgery can damage healthy tissue and cause wound problems. To reduce these side effects, researchers are testing a method called spatially fractionated grid radiation therapy (GRID). GRID delivers high doses of radiation to the tumor while limiting exposure to nearby healthy tissue. Early studies suggest GRID may be safer and more effective than traditional methods, but more research is needed. This study aims to learn whether GRID can improve treatment outcomes and reduce side effects, helping determine if it should become part of the standard care for soft tissue sarcoma. This is a hybrid decentralized study where some if not all assessments may be performed close to your home.

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

Participation in this study will include a screening visit that includes review of medical history and physical exam. Screening procedures include completing a survey on your ability to use your limb that is affected by extremity soft tissue sarcoma and making sure the biopsy sample that was used to diagnose your cancer can be used for research studies. If the biopsy cannot be used for research studies, then a mandatory repeat biopsy procedure would be performed. Once screening is completed, you will receive a single dose of GRID therapy followed by a mandatory biopsy of your cancer 3-4 days later. You will then complete your scheduled XRT and tumor removal surgery. The study team will follow-up on your general health and cancer progress and assess your ability to use your limb 3 and 6 months after your surgery. Participants may be seen at their local clinicals by their local health care providers (HCPs) for some or all trial related activities.

In-person visits:
2

Phone or online visits:
Varies

Total length of participation:
42 months

Looking for Specific Volunteers

Able to participate:

Patients with metastatic disease are allowed if the patient is planned to have a complete surgical resection of their primary disease and meet other eligibility
Must be willing to provide a mandatory research biopsy 72-96 hours after receiving GRID therapy and prior to XRT and tumor resection with one needle
Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment
Must have a life expectancy of at least 12 months.
Histological or cytological evidence/confirmation of extremity soft tissue sarcoma as determined by core-needle biopsy or excision biopsy (i.e., fine needle biopsy is not allowed). If

Not eligible if:

Subjects who have received prior radiotherapy to the tumor site.
Subjects who have undergone 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 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
Active infection requiring systemic antibiotics or antivirals.

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

Age & Gender

Visit Availability

Location

What will be asked of you

Looking for Specific Volunteers

Able to participate:

Not eligible if:

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Additional Study Information

Principal Investigator

Study Type

Study Topics

IRB Number

ClinicalTrials.gov

Helpful Links

Questions?