A Phase II Trial of CyberKnife Radiosurgery to Perioptic... | NCT02225197

Studies
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

NCT02225197

Sponsor

Community Cancer Center, Normal, Illinois

Status

Completed

Last Update Posted

Jul 25, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Tumor, Benign, Optic Nerve

Interventions

CyberKnife Radiosurgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Aug 22, 2014

First Submission Date that Met QC Criteria

Aug 25, 2014

First Posted Date

Aug 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CyberKnife Radiosurgery	Experimental		Radiation: CyberKnife Radiosurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CyberKnife Radiosurgery	Radiation	25 Gy delivered in 5 fractions of 5 Gy per fraction	CyberKnife Radiosurgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor status	To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shermian Woodhouse, MD	Community Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Community Cancer Center		Normal	Illinois	61761	United States

Condition Browse Module

MeSH Terms

ID	Term
D019574	Optic Nerve Neoplasms
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D003390	Cranial Nerve Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016634	Radiosurgery

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided