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Completed

NCT Number: NCT00983359

Stereotactic Radiation Therapy in Treating Patients With 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

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Key information

Conditions

Metastatic Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

radiation therapy

Radiation

Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.

Other names: Radiation

Primary outcomes

  1. 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

    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 outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to 5 years

    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.

  2. Time to Neurological Death

    Time frame: From time of enrollment up to 5 years

    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.

  3. Time to Systemic Death

    Time frame: From time of enrollment up to 5 years

    Descriptive analysis will be conducted using Kaplan-Meier survival analysis

  4. Karnofsky Decay Time

    Time frame: From time of enrollment up to 5 years

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2009
Registry last updated
Jun 6, 2017

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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