CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Stereotactic Radiosurgery using the CyberKnife System.radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528878
NCT01528878N/ACompleted

A Dose-finding, Safety and Preliminary Efficacy Study of Stereotactic Radiosurgery for Hepato-cellular Carcinoma and Metastatic Disease to the Liver.

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Feb 8, 2012·Updated Jul 26, 2018

In Brief

A clinical study evaluating Stereotactic Radiosurgery using the CyberKnife System. for Liver Neoplasms and 2 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2012
Enrollment StartApr 1, 2009
Primary CompletionAug 18, 2014
Study CompletionJan 28, 2016
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.4 years ago

Interventions

Stereotactic Radiosurgery using the CyberKnife System.radiation

Radiation: Stereotactic Radiosurgery using the CyberKnife System. The CyberKnife system has been cleared by the U.S. Food and Drug Administration (FDA) to treat lesions, tumors and conditions, anywhere in the body when radiation treatment is indicated. To address movement of target lesion during the respiratory cycle, the Synchrony™ option will be used. The Synchrony option precisely tracks tumors in or near the target organ as they move, enabling the highly focused beams of radiation to destroy the tumors with minimal injury to adjacent normal tissue. The Synchrony option records the breathing movements of a patient's chest and combines that information with sequential x-ray pictures of tiny markers inserted inside or in the proximity of the tumor to enable precise delivery of radiation during any point in the respiration cycle. The CyberKnife system with the Synchrony option enables reduced normal tissue exposure by using smaller treatment margins and increased accuracy.