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NCT Number: NCT01843413

Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tumors Metastatic to Brain Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Unspecified Adult Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

PRIMARY OBJECTIVES:

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)

SECONDARY OBJECTIVES:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Undergo SRS

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

cognitive assessment

Procedure

Ancillary studies

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Dose Escalation for Larger Brain Metastases: Phase I/II Study

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2013
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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