Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Metastatic Cancer
• Intervention / Treatment: Radiation: Radiation Therapy

Detailed Description

OBJECTIVES:

Primary

• To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.

Secondary

• To determine the overall survival rate at 6 months.
• To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
• To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
• To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.

OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.

After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
• Have cancer not originating in central nervous system (CNS)
• Karnofsky score of at least 60
• Given written consent
• At least 18 years of age

Exclusion Criteria:

• Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
• Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (conformal stereotactic radiation therapy); Patients undergo conformal stereotatic radiation	Radiation: Radiation Therapy; Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.; Other Names: Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status	Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered 'censored'. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.	Up to 5 years
Time to Neurological Death	Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered 'censored' observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an 'event' or neurological death.	From time of enrollment up to 5 years
Time to Systemic Death	Descriptive analysis will be conducted using Kaplan-Meier survival analysis	From time of enrollment up to 5 years
Karnofsky Decay Time	Time from enrollment to the date the patient's Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient's Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.	From time of enrollment up to 5 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Mario Ammirati, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Ammirati M, Kshettry VR, Lamki T, Wei L, Grecula JC. A prospective phase II trial of fractionated stereotactic intensity modulated radiotherapy with or without surgery in the treatment of patients with 1 to 3 newly diagnosed symptomatic brain metastases. Neurosurgery. 2014 Jun;74(6):586-94; discussion 594. doi: 10.1227/NEU.0000000000000325.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 23, 2009
• First Submitted That Met QC Criteria: September 23, 2009
• First Posted (Estimate): September 24, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; tumors metastatic to brain
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: OSU-06138; NCI-2011-03139 (Registry Identifier: Clinical Trials Reporting Program (CTRP))