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

Subjects are invited to take part in this study because they have soft tissue sarcoma and will be undergoing standard of care conventional radiotherapy (XRT) followed by surgery to treat their cancer. Advancements to this practice have been limited as increasing XRT doses prior to surgery has resulted in healthy tissue toxicity and post-operative wound complications. To overcome the negative results associated with higher doses of XRT, a method called spatially fractionated grid radiation therapy (GRID) may be used to distribute the amount of high dose radiation that is received at the site of their tumor. Early results with this method have shown that GRID therapy reduces the effects of radiation on normal tissue while delivering high doses of radiation to areas of the tumor. There are still questions that remain before GRID therapy can be incorporated into the standard of care therapy for soft tissue sarcoma treatment.

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?