Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mario Ammirati, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00983359
First received: September 23, 2009
Last updated: April 28, 2016
Last verified: April 2016
  Purpose

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


Condition Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Focal Therapy in the Treatment of Patients With 1-3 Brain Metastases

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Time to Neurological Death [ Time Frame: From time of enrollment up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Time to Systemic Death [ Time Frame: From time of enrollment up to 5 years ] [ Designated as safety issue: No ]
    Descriptive analysis will be conducted using Kaplan-Meier survival analysis

  • Karnofsky Decay Time [ Time Frame: From time of enrollment up to 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: April 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Radiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983359

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Mario Ammirati, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Mario Ammirati, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00983359     History of Changes
Other Study ID Numbers: OSU-06138  NCI-2011-03139 
Study First Received: September 23, 2009
Results First Received: March 24, 2016
Last Updated: April 28, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2016