A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

Part of paid clinical trials in Detroit, Michigan.

Sponsor
University of Nebraska
Study ID
NCT04222062
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Tumor - Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carmustine 7.7Mg Wafer — DRUG
    GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.

Study Details

This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.

Key Dates

Start date
Nov 6, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care Arm
    The tumor will be removed surgically. Within 6 weeks after surgery, the resection will be treated with stereotactic radiosurgery (SRS).
  • Experimental: GLIADEL Arm
    Once the tumor has been removed, GLIADEL wafers will be applied to the resection cavity. The number of wafers used will be determined by the size of the cavity. Enough wafers should be used so that as much of the cavity is covered as possible.

Primary Outcome Measure

Efficacy of GLIADEL compared to Stereotactic Radiosurgery (SRS) [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Henry FordDetroitMichigan48202
Coordinator
[email protected]
313-874-7513
Ian Lee, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Michele R Aizenberg Ansari, MD
[email protected]
402-559-9614

Find similar trials in Detroit, MI

By research site
Henry Ford· Detroit, MIUniversity of Nebraska Medical Center· Omaha, NE

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