Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

Completed

• Conditions: Malignant Glioma
• Interventions: Other: No intervention

• Registration Number: NCT02300506
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-10
• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-25
• Primary Completion: 2016-07-10
• Study Completion: 2016-07-10
• Status Verified: 2017-08
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No intervention	Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg, and enrolled in study GLI01S.

Primary Outcome Measures

Name	Time	Method
Survival rate	Up to 3 years	Survival rate of subjects measured up to 3 year after implantation