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

Phase 1/Phase 2
18 Years
Not Enrolling
Tumors Metastatic to Brain, Unspecified Adult Solid Tumor

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Trial Information

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


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

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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)

Outcome Time Frame:

Up to 4 months

Safety Issue:


Principal Investigator

Samuel Chao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Tumors Metastatic to Brain
  • Unspecified Adult Solid Tumor
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195