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A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02225197
Enrollment
10
Registered
2014-08-26
Start date
2007-12-31
Completion date
2017-10-31
Last updated
2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor, Benign, Optic Nerve

Keywords

Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus

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.

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.

Interventions

25 Gy delivered in 5 fractions of 5 Gy per fraction

Sponsors

Community Cancer Center, Normal, Illinois
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tumor status5 yearsTo determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026