Trial Outcomes & Findings for Radiosurgery for Glioblastoma Multiforme (NCT NCT00456612)

NCT ID: NCT00456612

Last Updated: 2017-03-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-03-06

Participant Flow

Participant milestones

Measure	Cyberknife Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
Overall Study STARTED	4
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Cyberknife Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Radiosurgery for Glioblastoma Multiforme

Baseline characteristics by cohort

Measure	Single Arm n=4 Participants Single arm Phase II Study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: consent to prgression or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1year

Outcome measures

Outcome data not reported

Adverse Events

Single Arm Study

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

Anand Mahadevan, MD

Beth Israel Deaconess Medical Center

Phone: 617-667-2345

Email: amahadev@bidmc.harvard.edu

Results disclosure agreements

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