GRID therapy for treating extremity soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.