Trial Outcomes & Findings for Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme (NCT NCT00253448)

Last Updated: 2011-08-29

Results Overview

Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Minimum of 5 years.

Results posted on

2011-08-29

Subjects recruited from 12/31/2002 to 5/8/2008 from medical clinic

One patient was not eligible for unknown reason

Participant milestones
Measure	Stereotactic Radiosurgery Plus Conventional Radiotherapy Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Stereotactic Radiosurgery Plus Conventional Radiotherapy Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
Overall Study Withdrawal by Subject	1

Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

Baseline characteristics by cohort
Measure	Stereotactic Radiosurgery Plus Conventional Radiotherapy n=35 Participants Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age Continuous	60.9 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

Timeframe: Minimum of 5 years.

Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years

Outcome measures
Measure	Stereotactic Radiosurgery Plus Conventional Radiotherapy n=35 Participants Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
Overall Survival After Treatment Entire Cohort	15.8 months Interval 11.0 to 19.9
Overall Survival After Treatment RTOG Glioma Recursive Partitioning Class 3 n=4	22 months Interval 22.0 to 22.0
Overall Survival After Treatment RTOG Glioma Recursive Partitioning Class 4 n=13	18.7 months Interval 14.5 to 29.1
Overall Survival After Treatment RTOG Glioma Recursive Partitioning Class 5 n=16	12.5 months Interval 9.2 to 18.5
Overall Survival After Treatment RTOG Glioma Recursive Partitioning Class 6 n=2	3.9 months Interval 2.7 to 5.1
Overall Survival After Treatment Patients receiving concurrent chemotherapy	20.8 months Interval 14.2 to 29.1
Overall Survival After Treatment Patients who were not candidates for chemotherapy	11 months Interval 7.2 to 18.5

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Stereotactic Radiosurgery Plus Conventional Radiotherapy n=35 participants at risk Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
Nervous system disorders CVA	2.9% 1/35 • Number of events 1
Nervous system disorders Re-operation for radiation necrosis	8.6% 3/35 • Number of events 3

Adverse event data not reported

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 937-395-8646