Neoplasm MetastasisNCT00904553
Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
An observational study of Neoplasm Metastasis, run by University of Rochester at 1 site in United States.
Trial summary
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment. The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Novalis Shaped Beam Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2009to 28 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the University of Rochester Medical Center
Who may be able to join
- Patients must have a previously histopathologically proven diagnosis of malignancy.
- Patients must be evaluated by Neurosurgery and Radiation Oncology
- Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
- All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
- All lesions must be <4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
- In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of <5 cm.
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- Patients must have a Karnofsky performance status ≥60.
- Extracranial disease must not be considered imminently life threatening (<2 month anticipated survival from extracranial disease).
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- KPS<60
- life expectancy > 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
- Conditions
- Neoplasm Metastasis
- Being tested
- Novalis Shaped Beam Surgery
- Keywords
- Brain, metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novalis Shaped Beam SurgeryRadiation
Treatment using Novalis SRS
| Study group | Role | What they receive |
|---|---|---|
| Novalis Shaped Beam Surgery | Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases. Receives: Radiation: Novalis Shaped Beam Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine toxicity of treatment with cranial SRS and resection
Measured: During treatment and long term follow-up
Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
Measured: During treatment and long term follow-up
Secondary outcomes (1)
Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.
Measured: Following surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study start14 Jan 2009
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Milano, MD,PhD, University of Rochester
- Investigators
- Michael Milano, MD PhD, Principal investigator, Department of Radiation Oncology, University of Rochester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904553
- Sponsor's protocol ID
- URBT07099
- Other IDs
- RSRB00023405
- Status last verified
- May 2022
- First submitted
- 15 May 2009
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
- ClinicalTrials.gov ID
- NCT00904553
- Acronym / sponsor ID
- URBT07099
- Conditions
- Neoplasm Metastasis
- Keywords
- Brain, metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 14 Jan 2009 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 19 May 2009 (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.
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novalis Shaped Beam Surgery | – | Radiation: Novalis Shaped Beam SurgeryPatients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the University of Rochester Medical Center
Key inclusion criteria (9 listed)
- Patients must have a previously histopathologically proven diagnosis of malignancy.
- Patients must be evaluated by Neurosurgery and Radiation Oncology
- Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
- All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
- All lesions must be <4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
Key exclusion criteria (2 listed)
- KPS<60
- life expectancy > 2 months
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 |
|---|---|---|
| Novalis Shaped Beam SurgeryTreatment using Novalis SRS | Radiation | Novalis Shaped Beam Surgery |
Primary outcome
Determine toxicity of treatment with cranial SRS and resection
Time frame: During treatment and long term follow-up
Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
Time frame: During treatment and long term follow-up
1 secondary outcome
Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.
Time frame: Following surgical resection
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 9 May 2022.
- Individual participant dataSharing planned: No
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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.
Michael Milano, MD PhD principal investigator
Department of Radiation Oncology, University of Rochester Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Metastasis, run by University of Rochester 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 9 inclusion and 2 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 9 May 2022. 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?
Determine toxicity of treatment with cranial SRS and resection (time frame: During treatment and long term follow-up). The study lists 2 primary outcomes in all. 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 9 May 2022.