NOA-11 / PDT

Controlled clinical trial to evaluate the safety and efficacy of stereotactic photodynamic therapy with 5-aminolevulinic acid (Gliolan) in recurrent glioblastoma

EudraCT Code: 2015-002727-25.

Phase IIb, multicenter, prospective, randomized, controlled Investigation according to AMG and MPG

This study will enroll patients with first recurrence of glioblastoma. Patients will be randomized. The treatment arm will receive stereotactic interstitial photodynamic therapy (iPDT), and the control arm will receive biopsy to confirm recurrence. Both patient collectives can be subsequently treated with any therapy except anti-angiogenesis inhibitors. The purpose of this study is to test the efficacy of iPDT in terms of progression-free survival. Secondary endpoints include overall survival and quality of life. The time span of the study will be 5 years, with an interim analysis after approximately 31 months.