NCT04222062

A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease

A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is being done to assess the efficacy of GLIADEL, a local chemotherapy, in preventing local recurrence of a metastatic brain tumor compared to stereotactic radiosurgery (SRS) after resection. 100 adult participants with one to four metastatic brain tumors with one tumor needing resection will be enrolled. Participants with prior radiation, lymphoma, small cell, germ cell, unknown primary, or anaplastic thyroid diagnoses will be ineligible. Life expectancy should be greater than 3 months. Participants will be randomized at the time of surgery to 1) GLIADEL placement at the time of resection or 2) SRS post-operatively to the resection cavity. Any other tumors (up to three) will have SRS as their primary treatment after surgery. SRS will take place within 6 weeks from surgery. Participants will be evaluated pre-operatively with Magnetic resonance imaging (MRI) brain and neuropsychological testing and will have immediate post-op MRI for extent of resection (EOR) determination. Participants will have SRS to the resection cavity if no GLIADEL was placed and all will have SRS to any other lesions. They will be followed at set intervals to evaluate for local recurrence and neurocognitive changes. The genome of the metastatic brain tumor will be compared to their primary and germline for identification of alterations.

Conditions

• Brain Tumor - Metastatic

Interventions

Type	Name	Description
DRUG	Carmustine 7.7Mg Wafer	GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.

Timeline

• Start date: 2020-11-06
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2020-01-09
• Last updated: 2025-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study