This trial is active, not recruiting.

Condition tumor, benign, optic nerve
Treatment cyberknife radiosurgery
Sponsor Community Cancer Center, Normal, Illinois
Start date December 2007
End date December 2016
Trial size 10 participants
Trial identifier NCT02225197, CK Perioptic-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
cyberknife radiosurgery CyberKnife
25 Gy delivered in 5 fractions of 5 Gy per fraction

Primary Outcomes

Local control
time frame: 5 years

Secondary Outcomes

time frame: 5 years

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Perioptic lesion within 2mm of the optic apparatus - Age >= 21 - KPS >= 50 - Planning Target Volume (PTV) <= 6.0 cm in maximal diameter Exclusion Criteria: - Malignant histology - Age < 21 - KPS <= 40 - Planning Target Volume (PTV) > 6.0 cm in maximal diameter - Prior whole brain XRT - Gross total resection

Additional Information

Official title A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors
Principal investigator Shermian Woodhouse, MD
Description The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Community Cancer Center, Normal, Illinois.