NCT01843413

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2013

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

12.1 years

First QC Date

April 26, 2013

Last Update Submit

July 18, 2025

Conditions

Tumors Metastatic to BrainUnspecified Adult Solid Tumor

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

  • 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)

    Up to 4 months

  • Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)

    Up to 2 years

Secondary Outcomes (2)

  • Incidence of adverse events as assessed by CTCAE version 4.0 (Phase II)

    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)

    Up to 12 months

Study Arms (1)

Treatment (SRS)

EXPERIMENTAL

Patients undergo SRS guided by CT and MRI.

Radiation: stereotactic radiosurgeryProcedure: quality-of-life assessmentProcedure: cognitive assessment

Interventions

stereotactic radiosurgeryRADIATION

Undergo SRS

Treatment (SRS)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Treatment (SRS)
cognitive assessmentPROCEDURE

Ancillary studies

Treatment (SRS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

RadiosurgeryMental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Samuel Chao, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Dose escalation for radiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

July 2, 2013

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations

US(1)