A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

Community Cancer Center, Normal, Illinois

Status: Completed

Conditions: Tumor, Benign, Optic Nerve

Treatments: Radiation: CyberKnife Radiosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02225197

CK Perioptic-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CyberKnife Radiosurgery

Experimental group

Treatment:

Radiation: CyberKnife Radiosurgery