OBJECTIVE: This study was a randomized, multicenter Phase II trial comparing the effect of perioperative implantation of 5-fluorouracil-releasing microspheres followed by early radiotherapy (Arm A) and early radiotherapy alone (Arm B) in patients with gross total resection of high-grade glioma. METHODS: Patients were randomized on clinical and radiological assumption of supratentorial high-grade glioma. All patients underwent surgery, and after resection and histological confirmation, patients randomized to Arm A received multiple injections of microsphere suspension (130 mg of 5-fluorouracil). Conventional fractionated radiotherapy (59.4 Gy) was initiated between the second and the seventh day after surgery for both arms. RESULTS: A total of 95 patients were randomized. Seventy-seven patients were treated and analyzed in intention to treat for efficacy and safety. Overall survival was 15.2 months in Arm A and 13.5 months in Arm B. In the subpopulation of patients with complete resection, overall survival was 15.2 months in Arm A versus 12.3 months in Arm B. However, these differences were not significant. Safety was acceptable with prophylactic high doses of corticosteroids. CONCLUSION: It may be hypothesized that the implantation of 5-fluorouracil-loaded microspheres in the wall of the cavity resection did increase the overall survival, but the present study was not designed and sufficiently powered to demonstrate this.
RCT Entities:
OBJECTIVE: This study was a randomized, multicenter Phase II trial comparing the effect of perioperative implantation of 5-fluorouracil-releasing microspheres followed by early radiotherapy (Arm A) and early radiotherapy alone (Arm B) in patients with gross total resection of high-grade glioma. METHODS:Patients were randomized on clinical and radiological assumption of supratentorial high-grade glioma. All patients underwent surgery, and after resection and histological confirmation, patients randomized to Arm A received multiple injections of microsphere suspension (130 mg of 5-fluorouracil). Conventional fractionated radiotherapy (59.4 Gy) was initiated between the second and the seventh day after surgery for both arms. RESULTS: A total of 95 patients were randomized. Seventy-seven patients were treated and analyzed in intention to treat for efficacy and safety. Overall survival was 15.2 months in Arm A and 13.5 months in Arm B. In the subpopulation of patients with complete resection, overall survival was 15.2 months in Arm A versus 12.3 months in Arm B. However, these differences were not significant. Safety was acceptable with prophylactic high doses of corticosteroids. CONCLUSION: It may be hypothesized that the implantation of 5-fluorouracil-loaded microspheres in the wall of the cavity resection did increase the overall survival, but the present study was not designed and sufficiently powered to demonstrate this.
Authors: Klaus Maier-Hauff; Ronny Rothe; Regina Scholz; Uwe Gneveckow; Peter Wust; Burghard Thiesen; Annelie Feussner; Andreas von Deimling; Norbert Waldoefner; Roland Felix; Andreas Jordan Journal: J Neurooncol Date: 2006-06-14 Impact factor: 4.130
Authors: Jessica M Grunda; L Burton Nabors; Cheryl A Palmer; David C Chhieng; Adam Steg; Tom Mikkelsen; Robert B Diasio; Kui Zhang; David Allison; William E Grizzle; Wenquan Wang; G Yancey Gillespie; Martin R Johnson Journal: J Neurooncol Date: 2006-06-14 Impact factor: 4.130
Authors: Brent D Weinberg; Ravi B Patel; Hanping Wu; Elvin Blanco; Carlton C Barnett; Agata A Exner; Gerald M Saidel; Jinming Gao Journal: Med Biol Eng Comput Date: 2008-06-04 Impact factor: 2.602