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

• Sponsor: Eisai Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02300506
• Collaborator: (none)
• Enrollment: 507
• Locations: 2
• Actual Duration (Months): 30
• Patients Per Site: 253.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma	Other: No intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 507 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
• Actual Study Start Date: Jan 10, 2014
• Actual Primary Completion Date: Jul 10, 2016
• Actual Study Completion Date: Jul 10, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg, and enrolled in study GLI01S.	Other: No intervention

Outcome Measures

Primary Outcome Measures

1. Survival rate [Up to 3 years]

   Survival rate of subjects measured up to 3 year after implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Malignant Glioma, patients enrolled in study GLI01S.

Exclusion criteria:

• Corresponding to contraindication of Gliadel.

• Not applicable to indications of Gliadel.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Eisai Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02300506
• Other Study ID Numbers: GLI02T
• First Posted: Nov 25, 2014
• Last Update Posted: Nov 5, 2018
• Last Verified: Aug 1, 2017

• Keywords provided by Eisai Co., Ltd.: Malignant Glioma; Glioblastoma multiforme
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Nov 5, 2018