An Evaluation of the Tolerability and Feasibility of Combining 5-Amino-Levulinic Acid (5-ALA) With Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial)
- To establish that the combined use of 5-ALA and Gliadel wafers during
fluorescence-guided radical brain tumor resection is safe and does not compromise
patients with primary glioblastoma from receiving or completing adjuvant standard
radiotherapy plus temozolomide.
- To gather preliminary evidence that the combined use of 5-ALA and Gliadel wafers at
surgery has the potential to improve clinical outcome, via measurement of time to
- To gather preliminary evidence that this regimen at surgery has the potential to
improve clinical outcome via measurement of survival at 24 months.
OUTLINE: This is a multicenter study.
Gliadel wafers are applied to resection cavity immediately after 5-ALA fluorescence-guided
radical brain tumor resection. After recovery from surgery (within 6 weeks of surgery when
possible ), patients receive adjuvant chemoradiotherapy comprising standard radiotherapy and
Tumor biopsy and blood sample may be collected at time of surgery for retrospective MGMT
After surgery, patients are followed up at post-surgical visits, during subsequent therapy
at routine clinic visits, and at 12, 18, and 24 months.
Peer reviewed and funded by Cancer Research UK.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, tolerability, and feasibility of combination intra-operative 5-ALA and Gliadel wafers prior to adjuvant radiotherapy plus temozolomide
Date of surgery to end of temozolomide and radiotherapy treatment
Cambridge University Hospitals NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency