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CompletedNCT02225197Updated Jul 25, 2019

A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

An interventional study of CyberKnife Radiosurgery in Tumor, Benign, Optic Nerve, sponsored by Community Cancer Center, Normal, Illinois. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Community Cancer Center, Normal, Illinois · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Tumor, Benign, Optic Nerve

Keywords

  • Perioptic
  • Stereotactic
  • Radiation
  • Benign brain tumor
  • Optic apparatus
03

In context

Lead sponsor

Community Cancer Center, Normal, Illinois is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    CyberKnife Radiosurgery

    Radiation: CyberKnife Radiosurgery

Interventions

  • RadiationCyberKnife Radiosurgery

    25 Gy delivered in 5 fractions of 5 Gy per fraction

    Also known as: CyberKnife

06

What researchers measure

Primary outcomes

  1. Tumor status

    To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.

    Time frame: 5 years

07

Study locations

1 site
  • Community Cancer Center
    Normal, Illinois 61761, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02225197
Lead sponsor
Community Cancer Center, Normal, Illinois
Responsible party
Sponsor
First posted
Aug 26, 2014
Start date
Dec 2007
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Jul 25, 2019

Study contacts

Shermian Woodhouse, MD
principal investigator · Community Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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