ALA and Photofrin fluorescence-guided resection and repetitive PDT in glioblastoma multiforme: a single centre Phase III randomised controlled trial.

Glioblastoma multiforme (GBM) carries dismal prognosis and cannot be eradicated surgically because of its wide brain invasion. The objective of this prospective randomised controlled trial was to evaluate ALA and Photofrin fluorescence-guided resection (FGR) and repetitive photodynamic therapy (PDT) in GBM. We recruited 27 patients; 13 were in the study group and 14 were in the control group. The mean survival of the study group was 52.8 weeks compared to 24.6 weeks in the control group (p<0.01). The study group gained on average 20 points on the Karnofsky performance score (p<0.05). There were no differences in complications or hospital stay between the two groups. The mean time to tumour progression was 8.6 months in the study group compared to 4.8 months in the control group (p<0.05). Therefore, ALA and Photofrin fluorescence-guided resection and repetitive PDT offered a worthwhile survival advantage without added risk to patients with GBM. A multicentre randomized controlled trial is warranted to confirm these results.

RCT Entities:   Population Interventions Outcomes