Tumors Metastatic to BrainPhase 1/2NCT01891318
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
A Phase 1/2 study testing radiosurgery, therapeutic conventional surgery and quality-of-life assessment in people with Tumors Metastatic to Brain, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors Metastatic to Brain
- What is being tested?
- radiosurgery, therapeutic conventional surgery and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jul 2013to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
- Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- Patient must have a Karnofsky performance score of ≥ 70
Who cannot join
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
- At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- Tumor located in the brainstem
- Imaging or cytologic evidence of leptomeningeal disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Withdrawn
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
- Recruiting
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Erin Murphy, MD, 866-223-8100, TaussigResearch@ccf.org
Erin Murphy, MD
About this study
This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)
II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
SECONDARY OBJECTIVES:
- To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.
II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.
III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.
OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.
The following outcomes were removed from the protocol in an amendment:
- Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \& Trailmaking Test B, and Trailmaking Test A
- QOL measured by FACT-BR and EORTC-QLQ30
- Conditions
- Tumors Metastatic to Brain
- Being tested
- radiosurgery, therapeutic conventional surgery, quality-of-life assessment
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiosurgeryRadiation
Also called radiation surgery
Undergo radiosurgery
therapeutic conventional surgeryProcedure or surgery
Undergo surgical resection
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiosurgery, surgery) | Experimental | Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection. Receives: Radiation: radiosurgery; Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
Measured: Day 0
Proportion of participants without local failure (Phase II)
Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study)
(Phase II)
The Kaplan-Meier method will be used.
Measured: Up to 3 years
Secondary outcomes (3)
Proportion of participants with distant brain failure
Rate of distant brain failure, defined as progression of brain metastases outside of the brain metastasis treated on study. The Kaplan-Meier method will be used.
Measured: Up to 3 years
Rate of radiation necrosis/steroid dependency
Rate of radiation necrosis/steroid dependency
Measured: Up to 3 years
Rate of salvage treatment
Number of patients that have any salvage treatment, including surgery, stereotactic radiosurgery (SRS), or whole brain radiation therapy (WBRT)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study start3 Jul 2013
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors Metastatic to BrainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Murphy, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891318
- Sponsor's protocol ID
- CASE7312
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2013
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- ClinicalTrials.gov ID
- NCT01891318
- Acronym / sponsor ID
- CASE7312
- Conditions
- Tumors Metastatic to Brain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Jul 2013 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Jul 2013 (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 Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)
II. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
SECONDARY OBJECTIVES:
- To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection.
II. To estimate the rate of salvage surgery, whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) for participants treated with neoadjuvant radiosurgery followed by surgical resection.
III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.
OUTLINE: This is a phase I, dose-escalation study of radiosurgery followed by a phase II study.
The following outcomes were removed from the protocol in an amendment:
- Changes in neurocognitive function as measured by the Hopkins Verbal Learning Test (HVLT), Controlled Oral Word Association (COWA) \& Trailmaking Test B, and Trailmaking Test A
- QOL measured by FACT-BR and EORTC-QLQ30
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiosurgery, surgery) | Experimental | Radiation: radiosurgery, Procedure: therapeutic conventional surgery, Procedure: quality-of-life assessmentPatients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
- Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
- Patient must have a Karnofsky performance score of ≥ 70
Key exclusion criteria (8 listed)
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
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 |
|---|---|---|
| radiosurgeryAlso: radiation surgeryUndergo radiosurgery | Radiation | Treatment (radiosurgery, surgery) |
| therapeutic conventional surgeryUndergo surgical resection | Procedure or surgery | Treatment (radiosurgery, surgery) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Treatment (radiosurgery, surgery) |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Day 0
MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
Proportion of participants without local failure (Phase II)
Time frame: Up to 3 years
Local control of brain metastases, as measured by proportion of participants without local failure (Local failure is tumor progression of the metastasis treated on the study) (Phase II) The Kaplan-Meier method will be used.
3 secondary outcomes
Proportion of participants with distant brain failure
Time frame: Up to 3 years
Rate of radiation necrosis/steroid dependency
Time frame: Up to 3 years
Rate of salvage treatment
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
Erin Murphy, MD principal investigator
Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing radiosurgery, therapeutic conventional surgery and quality-of-life assessment in people with Tumors Metastatic to Brain, run by Case Comprehensive Cancer Center at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Murphy, MD (1-866-223-8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Day 0). 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 Oct 2026.