This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain \[FACT-Br\]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.
Study Type
OBSERVATIONAL
Enrollment
272
To evaluate the overall survival rate for patients treated with Gliadel Wafer
Time from Gliadel placement to death
Time frame: up to 3 years
To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer
Time from Gliadel placement to death due to CNS tumor
Time frame: up to 3 years
To evaluate the progression-free survival rate for patients treated with Gliadel Wafer
Time from Gliadel placement to diagnosis of recurrent CNS tumor
Time frame: up to 3 years
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.
Frequency of SAEs
Time frame: up to 3 years
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.
Frequency of EOIs
Time frame: up to 3 years
To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.
frequency of ADRs
Time frame: up to 3 years
To evaluate change in patient health status over time via patient reported outcomes (PRO)
Change in FACT-Br score from baseline to end of study participation
Time frame: up to 3 years
To evaluate change in patient health status over time via a practitioner/proxy reported scale
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Spine and Neuro Center
Huntsville, Alabama, United States
Borrow Neurological Institute
Phoenix, Arizona, United States
Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center
Scottdale, Arizona, United States
Neurological Associates of Tucson, DBA Center for Neurosciences
Tucson, Arizona, United States
David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the
Los Angeles, California, United States
University of California, San Francisco Department of Neurological Surgery
San Francisco, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Baycare Medical Group
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Beacon Medical Group
Elkhart, Indiana, United States
...and 21 more locations
Change in KPS score from baseline to end of study participation
Time frame: up to 3 years
To evaluate the the reasons a physician does not insert Gliadel Wafers, in patients who were considered and consented for this Registry prior to the tumor resection procedure
reasons for screen failure
Time frame: up to 3 years