GRID therapy for treating extremity soft tissue sarcoma
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 testing a new type of radiation therapy called GRID to see if it can safely help people with high-risk soft tissue sarcoma before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06073067 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of GRID radiation therapy as a pre-operative treatment for patients with high-risk extremity soft tissue sarcoma. The approach aims to increase the radiation dose delivered to the tumor while minimizing toxicity to surrounding healthy tissues. Participants will receive a single priming dose of GRID therapy before standard radiotherapy and surgical tumor resection. The study focuses on assessing the safety and clinical efficacy of this innovative treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of extremity soft tissue sarcoma and an ECOG performance status of 0-2.
Not a fit: Patients with non-extremity soft tissue sarcoma or those with a performance status outside the specified range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve tumor response and reduce post-operative complications for patients with extremity soft tissue sarcoma.
How similar studies have performed: While GRID therapy has been used in various patients, there have been few formal studies evaluating its safety and efficacy, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill, Department of Radiation Oncology — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Theodore K Yanagihara, MD. PhD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Erin Jennings
- Email: erin_jennings@med.unc.edu
- Phone: 919-843-5400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.