A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

July 23, 2019 updated by: Community Cancer Center, Normal, Illinois

A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Normal, Illinois, United States, 61761
        • Community Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CyberKnife Radiosurgery
Radiation: CyberKnife Radiosurgery
25 Gy delivered in 5 fractions of 5 Gy per fraction
Other Names:
  • CyberKnife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor status
Time Frame: 5 years
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community Cancer Center, Normal, Illinois

Investigators

  • Principal Investigator: Shermian Woodhouse, MD, Community Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (ESTIMATE)

August 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK Perioptic-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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