The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II 
study 9806 to determine the safety and efficacy of daily thalidomide with 
radiation therapy in patients with newly diagnosed glioblastoma. Patients were 
treated with thalidomide (200 mg daily) from day one of radiation therapy, 
increasing by 100-200 to 1,200 mg every 1-2 weeks until tumor progression or 
unacceptable toxicity. The median survival time (MST) of all 89 evaluable 
patients was 10 months. When compared with the historical database stratified by 
recursive partitioning analysis (RPA) class, this end point was not different 
[hazard ratio (HR) = 1.18; 95 % CI: 0.95-1.46; P = 0.93]. The MST of RPA class 
III and IV patients was 13.9 versus 12.5 months in controls (HR = 0.99; 95 % CI: 
0.73-1.36; P = 0.48), and 4.3 versus 8.6 months in RPA class V controls 
(HR = 1.63, 95 % CI: 1.17-2.27; P = 0.99). In all, 34 % of patients discontinued 
thalidomide because of adverse events or refusal. The most common grade 3-4 
toxicities were venous thrombosis, fatigue, skin reactions, encephalopathy, and 
neuropathy. In conclusion, thalidomide given simultaneously with radiation 
therapy was safe, but did not improve survival in patients with newly diagnosed 
glioblastoma.