| General information |
| Database: | DB00598 |
| Objective: | They evaluated the efficacy and toxicity of hypofractionated intensitymodulated radiation therapy with concurrent and adjuvant temozolomide and bevacizumab in patients with newly diagnosed glioblastoma. |
| Authors: | Ney DE, et al |
| Title: | Phase II trial of hypofractionated intensitymodulated radiation therapy combined with temozolomide and bevacizumab for patients with newly diagnosed glioblastoma. |
| Journal: | J Neurooncol |
| Year: | 2015 |
| PMID: | 25524817 |
| Trial Design |
| Clinical Trial Id: | NCT01209442 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | hypofractionated intensitymodulated radiation therapy combined with temozolomide and bevacizumab |
| Study Type: | prospective, nonrandomized, singleinstitution study |
| Key Patients Feature: | Patients C18 years of age were eligible to participate inthis prospective, nonrandomized, singleinstitution study ifthey had newly diagnosed and histologically confirmedGBM. Karnofsky performance status (KPS) was requiredto be C60 % with a life expectancy of [12 weeks. Adequate hematologic, hepatic and renal function (defined asabsolute neutrophil count C1, 500/lL; hemoglobin levelC9 g/dL; platelet count C100, 000/lL; serum creatinineB1.5 mg/dL; serum SGOT and bilirubin B1.59 the upperlimit of normal) was required. Craniotomy or biopsy sitehad to be adequately healed and free of drainage or cellulitis at time of study entry. Therapeutic systemic anticoagulation was allowed. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with hypofractionated intensity modulated radiation therapy to the surgical cavity and residual tumor with a 1 cm margin (PTV1) to 60 Gy and to the T2 abnormality with a 1 cm margin (PTV2) to 30 Gy in 10 daily fractions over 2 weeks. Concurrent temozolomide (75 mg/m(2) daily) and bevacizumab (10 mg/kg) was administered followed by adjuvant temozolomide (200 mg/m(2)) on a standard 5/28 day cycle and bevacizumab (10 mg/kg) every 2 weeks for 6 months. |
| Primary End Point: | 6month progression free survival (PFS) |
| Secondary End Point: | overall survival (OS) and toxicity. |
| Patients Number: | NA |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 14.3 months |
| Median OS A vs. C: | 16.3 months |
| Adverse Event(agent arm): | Grade 4 hematologic toxicity included neutropenia (10 %) and thrombocytopenia (17 %). Grades 3/4 nonhematologic toxicity included fatigue (13 %), wound dehiscence (7 %) and stroke, pulmonary embolism and nausea each in 1 patient. |
| Conclusions: | The study was closed early to accrual due to this finding. This study demonstrated 90 % 6month PFS and OS comparable to historic data in patients receiving standard treatment. Bevacizumab did not prevent radiation necrosis associated with this hypofractionated radiation regimen and large PTV volumes may have contributed to high rates of presumed radiation necrosis. |