A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

NCT ID: NCT02225197

Last Updated: 2019-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Tumor, Benign, Optic Nerve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CyberKnife Radiosurgery

Group Type EXPERIMENTAL

CyberKnife Radiosurgery

Intervention Type RADIATION

25 Gy delivered in 5 fractions of 5 Gy per fraction

Interventions

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CyberKnife Radiosurgery

25 Gy delivered in 5 fractions of 5 Gy per fraction

Intervention Type RADIATION

Other Intervention Names

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CyberKnife

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Community Cancer Center, Normal, Illinois

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shermian Woodhouse, MD

Role: PRINCIPAL_INVESTIGATOR

Community Cancer Center

Locations

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Community Cancer Center

Normal, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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CK Perioptic-01

Identifier Type: -

Identifier Source: org_study_id

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