Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Metastatic Cancer
• Interventions: Radiation: Radiation Therapy

• Registration Number: NCT00983359
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2016-03-24
• Results First Submitted QC: 2016-04-28
• Results First Posted: 2016-06-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (conformal stereotactic radiation therapy)	Radiation Therapy	Patients undergo conformal stereotatic radiation

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status	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 Outcome Measures

Name	Time	Method
Karnofsky Decay Time	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.
Time to Systemic Death	From time of enrollment up to 5 years	Descriptive analysis will be conducted using Kaplan-Meier survival analysis
Progression-free Survival (PFS)	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.
Time to Neurological Death	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.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States