A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02225197|
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : January 25, 2018
The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.
|Condition or disease||Intervention/treatment||Phase|
|Tumor, Benign, Optic Nerve||Radiation: CyberKnife Radiosurgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
|Experimental: CyberKnife Radiosurgery||
Radiation: CyberKnife Radiosurgery
25 Gy delivered in 5 fractions of 5 Gy per fraction
Other Name: CyberKnife
- Local control [ Time Frame: 5 years ]To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
- Toxicity [ Time Frame: 5 years ]To determine the acute adverse and delayed effects of this regimen on the optic apparatus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225197
|United States, Illinois|
|Community Cancer Center|
|Normal, Illinois, United States, 61761|
|Principal Investigator:||Shermian Woodhouse, MD||Community Cancer Center|