Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Study Overview
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Brief Summary
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This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.

Detailed Description
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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.

Official Title
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Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice

Conditions
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CNS Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery. Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence. Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer. Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry. Exclusion Criteria: The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment. Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the overall survival rate for patients treated with Gliadel Wafer | Time from Gliadel placement to death | 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 | 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 | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. | Frequency of SAEs | up to 3 years | 
| To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. | Frequency of EOIs | up to 3 years | 
| To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. | frequency of ADRs | 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 | up to 3 years | 
| To evaluate change in patient health status over time via a practitioner/proxy reported scale | Change in KPS score from baseline to end of study participation | 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 | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gliadel, Carmustine wafer implant