Treatment of Bevacizumab Followed by Steroid in Radiation-induceded Brain Injury：a Randomized，Controlled and Single-blind Clinical Trail
试验速览
- 阶段
- 2 期
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients
研究概览
简要总结
Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy
详细描述
Radiation-induced brain injury 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 treatment of bevacizumab followed by steroid can alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma, and to compare the treating effect between combination of bevacizumab and steroid and bevacizumab alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.5 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; Hb >/=9.
- •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.
排除标准
- •evidence of metastatic disease;
- •evidence of tumor invasion to major vessels(e.g. the carotid);
- •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.
研究组 & 干预措施
Bevacizumab and steroid
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
干预措施: Bevacizumab and steroid (Drug)
Bevacizumab and placebo
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.
干预措施: Bevacizumab and placebo (Drug)
结局指标
主要结局
Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients
时间窗: Change form baseline to evaluation at 12 weeks
Change in MRI of radiation-induced brain necrosis in patients
次要结局
- Change of quality of life of patients after treatment(Change from baseline to evaluation at 12 weeks.)
- Change of neurologic function of patients after treatment(Change from baseline to evaluation at 12 weks.)
研究者
Yamei Tang
Associate Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University