NCT02225197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

9.8 years

First QC Date

August 22, 2014

Last Update Submit

July 23, 2019

Conditions

Tumor, Benign, Optic Nerve

Keywords

PeriopticStereotacticRadiationBenign brain tumorOptic apparatus

Outcome Measures

Primary Outcomes (1)

  • Tumor status

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

    5 years

Study Arms (1)

CyberKnife Radiosurgery

EXPERIMENTAL
Radiation: CyberKnife Radiosurgery

Interventions

CyberKnife RadiosurgeryRADIATION

25 Gy delivered in 5 fractions of 5 Gy per fraction

Also known as: CyberKnife
CyberKnife Radiosurgery

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Perioptic lesion within 2mm of the optic apparatus
  • Age \>= 21
  • KPS \>= 50
  • Planning Target Volume (PTV) \<= 6.0 cm in maximal diameter

You may not qualify if:

  • Malignant histology
  • Age \< 21
  • KPS \<= 40
  • Planning Target Volume (PTV) \> 6.0 cm in maximal diameter
  • Prior whole brain XRT
  • Gross total resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Cancer Center

Normal, Illinois, 61761, United States

Location

MeSH Terms

Conditions

Optic Nerve NeoplasmsBrain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Cranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesEye DiseasesCentral Nervous System NeoplasmsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Shermian Woodhouse, MD

    Community Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 26, 2014

Study Start

December 1, 2007

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

US(1)