BACKGROUND: The radiochemotherapy regimen concomitantly employing @entity2903 ( @entity2904 ) chemotherapy and radiotherapy (RT) 4 weeks after surgery, followed by 6 cycles of @entity2904 is a common treatment for @entity463 ( @entity463 ). However, its median overall survival (OS) is only 14.6 months. This study was to explore the effectiveness and safety of early @entity2904 chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. METHODS: A randomized, parallel group, open-label study of 99 newly diagnosed @entity463 @entity1 was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. @entity1 were treated with concomitant radiochemotherapy regimen plus early postsurgical @entity2903 (early @entity2904 group) or standard concomitant radiochemotherapy regimen (control group). Overall response was assessed based on objective @entity5 assessments, administration of corticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event (AE), and @entity16 were measured for 24 months of follow-up. The primary efficacy endpoint of this study was overall survival (OS). The secondary endpoint was progression free survival (PFS). RESULTS: The median OS time in the early @entity2904 group was 17.6 months, compared with 13.2 months in the control group (log-rank test P = 0.021). In addition, the OS rate in the early @entity2904 group was higher at 6, 12, and 18 months than in the control group, respectively (P < 0.05). The median PFS time was 8.7 months in the early @entity2904 group and 10.4 months in the control group (log-rank test P = 0.695). AEs occurred in 29 (55.8%) and 31(73.8%) @entity1 respectively in early and control groups, including @entity390 (15.4% vs. 33.3%), @entity391 (7.7% vs. 28.6%), fever (7.7% vs. 11.9%), and @entity10 (3.8% vs. 23.8%). Only 30.8% and 33.3% were drug-related, respectively. CONCLUSIONS: Addition of @entity2904 chemotherapy in the early break of the standard concomitant radiochemotherapy regimen was well tolerated and significantly improved the OS of the @entity463 @entity1 , compared with standard concomitant radiochemotherapy regimen. However, a larger randomized trial is warranted to verify these results.

Does Early Postsurgical XXXX Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed @entity463 @entity1 ? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity2904 :: ('CHEBI:72564', 'Chemical') :: ['TMZ'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neurological condition'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity2903 :: ('MESH:C047246', 'Chemical') :: ['temozolomide'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity463 :: ('MESH:D005909', 'Disease') :: ['GBM', 'glioblastoma']
@entity2903 :: (MESH:C047246,Chemical) :: ['Temozolomide']
