Tumors Metastatic to BrainPhase 1NCT01843413
Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases
A Phase 1 study testing stereotactic radiosurgery, quality-of-life assessment and cognitive assessment in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors Metastatic to Brain, Unspecified Adult Solid Tumor
- What is being tested?
- stereotactic radiosurgery, quality-of-life assessment and cognitive assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2013to Aug 2025
- Phase
- Phase 1
- 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
- Any patient undergoing SRS for brain metastases
- Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter
- Patients may have had prior therapy including:
- Whole brain radiation therapy (WBRT) > 3 months ago
- SRS to other brain metastases
- Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
- Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
- Patient must be able to provide written informed consent
Who cannot join
- Patients receiving SRS to resection bed
- Planned concurrent WBRT
- Leptomeningeal metastases
- Small cell lung cancer, lymphoma, and germ cell histologies
- Inability to participate in study activities due to physical or mental limitations
- Inability or unwillingness to return for all the required follow-up visits
Show all 9Show fewer
- Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0
- Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm
- Brainstem location is excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Dose Escalation for Larger Brain Metastases: Phase I/II Study
This phase I/II trial studies the side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II)
SECONDARY OBJECTIVES:
- To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS.
III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI).
After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.
- Being tested
- stereotactic radiosurgery, quality-of-life assessment, cognitive assessment
- Keywords
- unspecified adult solid tumor, protocol specific
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiosurgeryRadiation
Undergo SRS
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
cognitive assessmentProcedure or surgery
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SRS) | Experimental | Patients undergo SRS guided by CT and MRI. Receives: Radiation: stereotactic radiosurgery; Procedure: quality-of-life assessment; Procedure: cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Measured: Up to 4 months
Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
Measured: Up to 2 years
Secondary outcomes (2)
Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)
Toxicity will be summarized as frequencies and percentages with a corresponding exact 95% confidence interval.
Measured: Up to 2 years
Quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) and the European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire Core 30 (QLQ30)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study start2 Jul 2013
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (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.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation for radiotherapy
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Chao, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843413
- Sponsor's protocol ID
- CASE8312
- Status last verified
- Jul 2025
- First submitted
- 26 Apr 2013
- Last updated
- 20 Jul 2025
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation for Larger Brain Metastases: Phase I/II Study
- ClinicalTrials.gov ID
- NCT01843413
- Acronym / sponsor ID
- CASE8312
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Apr 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 side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- To determine the incidence of acute and long-term toxicities with increasing dose of stereotactic radiosurgery (SRS). (Phase I) II. To determine if local control may be improved with increasing doses of SRS. (Phase II)
SECONDARY OBJECTIVES:
- To determine the risk of acute and long-term toxicity with increasing dose of SRS. (Phase II) II. To determine if there is increased neurocognitive toxicity with increased dose of SRS.
III. To determine the rate of radiation necrosis/steroid dependency. IV. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis.
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Patients undergo SRS guided by computer tomography (CT) and magnetic resonance imaging (MRI).
After completion of treatment, patients are followed up at 1-2, 3, 6, 9, and 12 months, every 3 months for 2 years, and then every 4 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation for radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Treatment (SRS) | Experimental | Radiation: stereotactic radiosurgery, Procedure: quality-of-life assessment, Procedure: cognitive assessmentPatients undergo SRS guided by CT and MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any patient undergoing SRS for brain metastases
- Lesions to be treated under this protocol must be > 2 cm, but =< 4.0 cm in diameter
- Patients may have had prior therapy including:
- Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront
- Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies
Key exclusion criteria (9 listed)
- Patients receiving SRS to resection bed
- Planned concurrent WBRT
- Leptomeningeal metastases
- Small cell lung cancer, lymphoma, and germ cell histologies
- Inability to participate in study activities due to physical or mental limitations
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 |
|---|---|---|
| stereotactic radiosurgeryUndergo SRS | Radiation | Treatment (SRS) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Treatment (SRS) |
| cognitive assessmentAncillary studies | Procedure or surgery | Treatment (SRS) |
Primary outcome
Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Time frame: Up to 4 months
Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
Time frame: Up to 2 years
2 secondary outcomes
Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)
Time frame: Up to 2 years
Quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) and the European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire Core 30 (QLQ30)
Time frame: Up to 12 months
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 20 Jul 2025.
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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.
Samuel Chao, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stereotactic radiosurgery, quality-of-life assessment and cognitive assessment in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, run by Case Comprehensive Cancer Center 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. 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.
What does this 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.
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?
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?
Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) (time frame: Up to 4 months). 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 20 Jul 2025.