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

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ClinicalTrials.gov Identifier: NCT02300506
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( 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).

Condition or disease Intervention/treatment
Malignant Glioma Other: No intervention

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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 : January 10, 2014
Actual Primary Completion Date : July 10, 2016
Actual Study Completion Date : July 10, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Carmustine

Group/Cohort 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



Primary Outcome Measures :
  1. Survival rate [ Time Frame: Up to 3 years ]
    Survival rate of subjects measured up to 3 year after implantation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed malignant glioma treated by surgery
Criteria

Inclusion criteria:

  • Malignant Glioma, patients enrolled in study GLI01S.

Exclusion criteria:

  • Corresponding to contraindication of Gliadel.
  • Not applicable to indications of Gliadel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300506


Locations
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02300506     History of Changes
Other Study ID Numbers: GLI02T
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: August 2017

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Malignant Glioma
Glioblastoma multiforme

Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents