Clinical Trials Directory

Trials / Terminated

TerminatedNCT00456612

Radiosurgery for Glioblastoma Multiforme

Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Beth Israel Deaconess Medical Center · Academic / Other
Sex
All
Age
66 Years
Healthy volunteers
Not accepted

Summary

Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life. To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status. Secondary: Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.

Detailed description

Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS\<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.

Conditions

Interventions

TypeNameDescription
PROCEDURECyberKnifeRadiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.

Timeline

Start date
2007-02-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2007-04-05
Last updated
2017-03-06
Results posted
2015-10-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00456612. Inclusion in this directory is not an endorsement.