JPRN-jRCT2080224914尚未招募2 期
A Randomized Double-blind Multicenter trial to Assess the Efficacy and Safety of Bevacizumab for Neurofibromatosis Type 2
Kiyoshi Saito0 个研究点目标入组 60 人开始时间: 2019年10月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •1. Written informed consent must be obtained.
- •2. For the participants younger than 20 years old, the written informed consent must be obtained from legal representatives.
- •3. Male or female aged 18-64 (inclusive).
- •4. NF2 patients who fulfill either conditions below.
- •(1) have bilateral acoustic neuromas demonstrated by an MRI study
- •(2) have a unilateral acoustic neuroma demonstrated by an MRI study, and at least one of his/her parents, sons, daughters, brothers, sisters is diagnosed as NF2.
- •5. A Japanese native speaker and evaluable by the speech discrimination test in Japanese.
- •6. At least one side of the ear with an acoustic neuroma fulfils both conditions below.
- •(1) The acoustic neuroma has not been treated by radiotherapy.
- •(2) Hearing test of the same side of ear meets a criterion; maximum word recognition scores 80% or less, and pure tone averages less than 100dB
- •7. Karnofsky Performance Status greater than or equal to 60%, and general condition allows follow-up and treatment in outpatient clinic.
- •8. Has appropriate organ functions
排除标准
- •1. History of bevacizumab treatment before this clinical trial.
- •2. History of VEGFR vaccine therapy.
- •3. A plan to undergo surgery within the coming 6 months.
- •4. Major surgery performed within 28 days prior to registration, or wound not healed after any kind of surgery at the time point of registration.
- •5. Presence of a significant traumatic injury or bone fracture that has not cured.
- •6. Suffering from uncontrolled hypertension at the time point of registration (unable to control blood pressure below 150 mmHg (systolic) or 110 mmHg (diastolic).
- •7. Presence of hypertension crisis or hypertensive encephalopathy, or past history of either of them.
- •8. Presence of congestive heart failure (New York Heart Association Class II or worse) at the time point of registration.
- •9. Presence of unstable angina or acute myocardial infarction at the time point of registration, or has past history of either of them within 6 months.
- •10. Presence of symptomatic cerebrovascular diseases (subarachnoid hemorrhage, cerebral infarction, or transient ischemic attack, etc.) at the time point of registration, or has past history of either of the above within 6 months.
- •11. Presence of vascular diseases (arterial/venous thrombosis or aortic aneurysm, etc.) that require treatments at the time point of registration, or has past history of either of them.
- •12. Usage or necessity of antiplatelet drugs, vitamin K antagonists, or anticoagulation drugs of any kind in a therapeutic dose.
- •13. Presence of hemoptysis of CTCAE grade 2 or above at the time point of registration, or has past history of it within 1 months.
- •14. Bleeding tendency (coagulopathy) at the time point of registration.
- •15. Presence of gastrointestinal perforation/fistula, or abdominal abscess at the time point of registration, or has past history of either of them within 6 months.
- •16. Diagnosis of cancer with disease-free periods of less than 5 years, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer, or gastrointestinal tract cancer that has been managed and cured by endoscopic mucosal resection).
- •17. Presence of infectious diseases that require treatments with antibiotics, anti-viral drugs, or anti-fungal drugs at the time point of registration.
- •18. Allergic to drugs made from CHO or recombinant humanized antibodies.
- •19. Unable to do MRI.
- •20. The target ear is suffering from a disease other than NF2 which causes hearing loss.
- •21. Women who are pregnant, breastfeeding, premenopausal women who have a positive pregnancy test, or women who are not willing to use contraception during the study period. If amenorrhea has continued for more than 2 years from the last menstrual period, it is considered postmenopausal.
- •22. Men who are not willing to practice contraception during the study.
- •23. When the investigators determine that participation of the subject in this study is inappropriate.
研究者
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