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Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01843413
Recruitment Status : Recruiting
First Posted : April 30, 2013
Last Update Posted : February 11, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Tumors Metastatic to Brain Unspecified Adult Solid Tumor Radiation: stereotactic radiosurgery Procedure: quality-of-life assessment Procedure: cognitive assessment Not Applicable

Detailed Description:


I. 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)


I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation for radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation for Larger Brain Metastases: Phase I/II Study
Actual Study Start Date : July 2, 2013
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Treatment (SRS)
Patients undergo SRS guided by CT and MRI.
Radiation: stereotactic radiosurgery
Undergo SRS

Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Procedure: cognitive assessment
Ancillary studies

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II) [ Time Frame: Up to 2 years ]
    Toxicity will be summarized as frequencies and percentages with a corresponding exact 95% confidence interval.

  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01843413

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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel T. Chao    216-445-7876   
Principal Investigator: Samuel T. Chao         
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Samuel Chao, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center Identifier: NCT01843413    
Other Study ID Numbers: CASE8312
NCI-2013-00845 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Case Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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