Trial Outcomes & Findings for Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases (NCT NCT00814463)

Results Overview

The number of months for local recurrence via MRI

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

12 months

Results posted on

2019-02-26

Patients were recruited from the Duke Comprehensive Cancer Center from 6/12/2008 - 6/5/2009.

Participant milestones
Measure	Post-operative SRS All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Post-operative SRS All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study.
Overall Study Lost to Follow-up	1

Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Baseline characteristics by cohort
Measure	Post-operative SRS n=1 Participants All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants
Age, Continuous	67 years n=39 Participants
Sex: Female, Male Female	1 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Region of Enrollment United States	1 Participants n=39 Participants

Timeframe: 12 months

The number of months for local recurrence via MRI

Outcome measures
Measure	Post-operative SRS n=1 Participants All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study. QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study. Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions. MMSE : Neurocognitive function via MMSE done every 3 months for length of study. MRI : MRI done every 3 months for the length of the study.
Recurrence Rate at the Surgical Site as Measured by MRI	3.5 Months

Timeframe: 12 months