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A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

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ClinicalTrials.gov Identifier: NCT02225197
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Community Cancer Center, Normal, Illinois

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.


Condition or disease Intervention/treatment Phase
Tumor, Benign, Optic Nerve Radiation: CyberKnife Radiosurgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: CyberKnife Radiosurgery Radiation: CyberKnife Radiosurgery
25 Gy delivered in 5 fractions of 5 Gy per fraction
Other Name: CyberKnife



Primary Outcome Measures :
  1. Local control [ Time Frame: 5 years ]
    To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 5 years ]
    To determine the acute adverse and delayed effects of this regimen on the optic apparatus



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, Illinois
Community Cancer Center
Normal, Illinois, United States, 61761
Sponsors and Collaborators
Community Cancer Center, Normal, Illinois
Investigators
Principal Investigator: Shermian Woodhouse, MD Community Cancer Center

Responsible Party: Community Cancer Center, Normal, Illinois
ClinicalTrials.gov Identifier: NCT02225197     History of Changes
Other Study ID Numbers: CK Perioptic-01
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Community Cancer Center, Normal, Illinois:
Perioptic
Stereotactic
Radiation
Benign brain tumor
Optic apparatus

Additional relevant MeSH terms:
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Peripheral Nervous System Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Eye Diseases