A Phase II Trial of CyberKnife 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.

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Key information

Conditions

Tumor, Benign, Optic Nerve Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cranial Nerve Diseases Cranial Nerve Neoplasms Eye Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Optic Nerve Diseases Optic Nerve Neoplasms Peripheral Nervous System Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Cancer Center

Normal, Illinois, 61761, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CyberKnife Radiosurgery

Radiation

25 Gy delivered in 5 fractions of 5 Gy per fraction

Other names: CyberKnife

Primary outcomes

Tumor status

Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Community Cancer Center, Normal, Illinois

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2017
Study completion: 2017
First posted: Aug 26, 2014
Registry last updated: Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed