Phase
Condition
Sarcoma
Treatment
GRID therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Written informed consent was obtained to participate in the study and HIPAAauthorization for the release of personal health information. Subjects are willingand 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 (KarnofskyPerformance Status equivalent of 50 - 100).
Histological or cytological evidence/confirmation of extremity soft tissue sarcomaas determined by core-needle biopsy or excision biopsy. If the diagnostic tissue isnot available or sufficient to perform correlative studies, must be willing toprovide the mandatory pre-treatment core-needle biopsy. In some cases of extremitySTS, subjects undergo an attempted surgical resection for a presumed benigncondition and the specimen reveals malignancy. Such subjects are allowed so long asa complete, oncologic, resection was not performed/attempted and there is ≥ 5 cm ofthe remaining primary tumor.
Exclusion
Exclusion Criteria:
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 whohave developed tumor recurrence after resection.
History of serious or non-healing wound, ulcer, or bone fracture in the treatmentlimb within the last 5 years.
History of clinically significant lymphedema in the treated limb.
History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (anytype), or other collagen vascular disease that may pose a relative contraindication,due to increased risk of skin or soft tissue toxicity, with radiation.
Study Design
Connect with a study center
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
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