A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
Primary Purpose
Tumor, Benign, Optic Nerve
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Tumor, Benign, Optic Nerve focused on measuring Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus
Eligibility Criteria
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
Sites / Locations
- Community Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CyberKnife Radiosurgery
Arm Description
Outcomes
Primary Outcome Measures
Tumor status
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT02225197
First Posted
August 22, 2014
Last Updated
July 23, 2019
Sponsor
Community Cancer Center, Normal, Illinois
1. Study Identification
Unique Protocol Identification Number
NCT02225197
Brief Title
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
Official Title
A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Community Cancer Center, Normal, Illinois
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Benign, Optic Nerve
Keywords
Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CyberKnife Radiosurgery
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Radiosurgery
Other Intervention Name(s)
CyberKnife
Intervention Description
25 Gy delivered in 5 fractions of 5 Gy per fraction
Primary Outcome Measure Information:
Title
Tumor status
Description
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shermian Woodhouse, MD
Organizational Affiliation
Community Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
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