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1. Late Gastrointestinal (GI) Toxicity (Time Frame - 3 to 24 months post-SBRT initiation): Proportion of subjects experiencing late GI toxicity after SBRT treatment with or without placement of the SpaceOAR Vue System hydrogel. Late GI toxicity is defined as the occurrence of a Grade 2 or greater GI adverse event (NCI CTCAE v4) between 3- and 24-months post-SBRT initiation
Secondary outcome:
1. EPIC-26 bowel score (Time Frame - 24 months post-SBRT initiation): Proportion of subjects experiencing a decrease in EPIC-26 bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation.
SpaceOAR Vue System: The SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy"
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