Trial Outcomes & Findings for Stereotactic Radiation Therapy in Treating Patients With Brain Metastases (NCT NCT00983359)

NCT ID: NCT00983359

Last Updated: 2017-06-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2017-06-06

Participant Flow

Patient recruitment period was June 2007 to March 2010

Participant milestones

Measure	Treatment (Conformal Stereotactic Radiation Therapy) Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Overall Study STARTED	40
Overall Study Not Eligible for Analysis	1
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

Baseline characteristics by cohort

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=39 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Age, Customized ≤60	20 patients n=5 Participants
Age, Customized >60	19 patients n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 patients n=5 Participants
Extracranial metastases Absent	19 patients n=5 Participants
Extracranial metastases Present	20 patients n=5 Participants
Number of brain metastases 1	25 patients with brain metastases n=5 Participants
Number of brain metastases 2	4 patients with brain metastases n=5 Participants
Number of brain metastases 3	8 patients with brain metastases n=5 Participants
Number of brain metastases ≥4	2 patients with brain metastases n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=39 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status	5 patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=39 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Progression-free Survival (PFS)	11 months Interval 4.0 to 21.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=5 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Time to Neurological Death	13 months Interval 5.0 to 18.0

SECONDARY outcome

Timeframe: From time of enrollment up to 5 years

Descriptive analysis will be conducted using Kaplan-Meier survival analysis

Outcome measures

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=39 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Time to Systemic Death	16 months Interval 9.0 to 24.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment (Conformal Stereotactic Radiation Therapy) n=39 Participants Patients undergo conformal stereotatic radiation Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.
Karnofsky Decay Time	14 months Interval 1.0 to 62.0

Adverse Events

Treatment (Conformal Stereotactic Radiation Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mario Ammirati, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-1970

Email: Mario.Ammirati@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place