effect of bevacizumab on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Adverse Effect of Radiation Therapy; Brain Necrosis

Summary: bevacizumab may have a better effect on brain necrosis caused by radiotherapy.this randomized trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. the effect will be compared with outcomes in patients receiving steroid therapy.

radiation-induced brain necrosis is a severe complication of radiotherapy in patients with nasopharyngeal carcinoma. current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. this study is a randomized, single blind clinical study. the primary aim of this study is to determine whether bevacizumab can alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma, and to compare the treating effect between bevacizumab and steroid.

Eligibility criteria:
inclusion criteria: * patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma. * prior irradiation \>/= 6 months prior to study entry. * radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence. * age\>/= 18 years. because on dosing or adverse event data are currently not available on the use of bevacizumab in patients \<18years old. * no prior bevacizumab therapy. * no evidence of very high intracranial pressure that suggests brain hernia and needs surgery. * fertile women who are willing to take contraception during the trial. * routine laboratory studies with bilirubin \ /= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; hb \>/=9.0. pt, aptt, inr in a normal range. * if with history of seizures, patients should be on anticonvulsant therapy. however, preference will be enzyme-non-inducing anticonvulsants. * ability to understand and willingness to sign a written informed consent document. * the patient has no active bleeding or pathological condition that carries a high risk of bleeding; there is no evidence of serious or non-healing wound, ulcer or bone fracture. exclusion criteria: * patients with any of the following should be excluded: 1) evidence of metastatic disease; 2)evidence of tumor invasion to major vessels(e.g. the carotid); 3) history of bleeding related to tumor or radiotherapy during or after the completion of radiation. * evidence of active central nervous system hemorrhage. * history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment. * inadequately controlled hypertension (systolic blood pressure (sbp) \> 140 mmhg and/or diastolic blood pressure (dbp) \> 90 mmhg despite antihypertensive medication) * severe complications: 1) history of large vessel cerebrovascular accident (cva) within 6 months; 2) myocardial infarction or unstable angina within 6 months; 3) new york heart association grade ii or greater congestive heart failure; 4) serious and inadequately controlled cardiac arrhythmia; 5) significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 6) clinically significant peripheral vascular disease; 7) severe infection. * evidence of bleeding diathesis or coagulopathy. * patients who have received steroid therapy for radiation-induced brain necrosis before the study. * history of anaphylactic response to bevacizumab.

Keywords: radiation-induced brain necrosis nasopharyngeal carcinoma bevacizumab methylprednisolone