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Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300532
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.

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

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Study Type : Observational
Actual Enrollment : 561 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Actual Study Start Date : January 10, 2013
Actual Primary Completion Date : July 10, 2014
Actual Study Completion Date : March 24, 2015

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
Other: No intervention



Primary Outcome Measures :
  1. Number of Adverse Events/Serious Adverse Events [ Time Frame: Up to 3 months ]

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



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:

  • All-patient of Gliadel implantation

Exclusion criteria:

  • None

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): NCT02300532


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: NCT02300532     History of Changes
Other Study ID Numbers: GLI01S
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: January 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