Tumor, Benign, Optic NerveNCT02225197
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors
A study testing CyberKnife Radiosurgery in people with Tumor, Benign, Optic Nerve, run by Community Cancer Center, Normal, Illinois at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tumor, Benign, Optic Nerve
- What is being tested?
- CyberKnife Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perioptic lesion within 2mm of the optic apparatus
- Age >= 21
- KPS >= 50
- Planning Target Volume (PTV) <= 6.0 cm in maximal diameter
Who cannot join
- Malignant histology
- Age < 21
- KPS <= 40
- Planning Target Volume (PTV) > 6.0 cm in maximal diameter
- Prior whole brain XRT
- Gross total resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Fractionated CyberKnife Stereotactic 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.
Read the 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.
- Conditions
- Tumor, Benign, Optic Nerve
- Being tested
- CyberKnife Radiosurgery
- Keywords
- Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus
- Medical subject headings
- Optic Nerve Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife RadiosurgeryRadiation
Also called CyberKnife
25 Gy delivered in 5 fractions of 5 Gy per fraction
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife Radiosurgery | Experimental | Not described Receives: Radiation: CyberKnife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor status
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startDec 2007
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, Benign, Optic NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Cancer Center, Normal, Illinois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shermian Woodhouse, MD, Principal investigator, Community Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225197
- Sponsor's protocol ID
- CK Perioptic-01
- Status last verified
- Jul 2019
- First submitted
- 22 Aug 2014
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors
- ClinicalTrials.gov ID
- NCT02225197
- Acronym / sponsor ID
- CK Perioptic-01
- Conditions
- Tumor, Benign, Optic Nerve
- Keywords
- Perioptic, Stereotactic, Radiation, Benign brain tumor, Optic apparatus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Community Cancer Center, Normal, IllinoisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyberKnife Radiosurgery | Experimental | Radiation: CyberKnife Radiosurgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Perioptic lesion within 2mm of the optic apparatus
- Age >= 21
- KPS >= 50
- Planning Target Volume (PTV) <= 6.0 cm in maximal diameter
Key exclusion criteria (6 listed)
- Malignant histology
- Age < 21
- KPS <= 40
- Planning Target Volume (PTV) > 6.0 cm in maximal diameter
- Prior whole brain XRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnife RadiosurgeryAlso: CyberKnife25 Gy delivered in 5 fractions of 5 Gy per fraction | Radiation | CyberKnife Radiosurgery |
Primary outcome
Tumor status
Time frame: 5 years
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shermian Woodhouse, MD principal investigator
Community Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife Radiosurgery in people with Tumor, Benign, Optic Nerve, run by Community Cancer Center, Normal, Illinois at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor status (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.