NL-OMON44004已完成3 期
Phase III intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with concomitant and adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma. - Codeleted
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
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
- 18 至 99（—）
入选标准
- •* Provide informed written consent.
- •* Patient willing to provide tissue samples for deletion status
- •* *18 years of age.
- •* Newly diagnosed and <3 months from surgical diagnosis.
- •* Histological confirmation of anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma (grade 3-4)
- •* Loss of heterozygosity for both 1p and 19q (*co-deletion*).
- •* *2 weeks from the date of surgery and must have recovered from the effects of surgery
- •* Adequate hematological, renal and liver function
- •* Negative pregnancy test (B-HCG) done *7 days prior to registration, for women of childbearing potential only.
- •* Willing and able to complete neurocognitive/QOL questionnaire(s) by themselves or with assistance
- •* ECOG performance status (PS) of 0 1 or 2
排除标准
- •* For women: not pregnant or nursing, for all patients of childbearing potential: willing to employ adequate contraception
- •* No prior surgery, radiotherapy or chemotherapy for any CNS neoplasm
- •* No co-morbid systemic illnesses or other severe concurrent disease which, would interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- •* No concomitant serious immuno-compromised status (other than that related to concomitant steroids).
- •* No active uncontrolled systemic infection or HIV.
- •* Not receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- •* No active other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix. If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer.
- •* No history of myocardial infarction *6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
研究者
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