ACTRN12620000402943撤回3 期
Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Pre-Registration
- •* This review is mandatory prior to registration to confirm eligibility; patients must
- •be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible
- •- Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review
- •- Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility,
- •the 1p/19q analysis results will be accepted from the local site, as determined
- •by either a locally available or reference laboratory; acceptable methods for
- •determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by
- •genomic sequencing or methylomic analyses;
- •- Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic
- •analyses; this should be performed at the local site
- •Registration
- •- Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as
- •long as the patient has not received prior radiation or prior chemotherapy
- •- Histological evidence of World Health Organization (WHO) grade III anaplastic glioma
- •or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced
- •laboratory qualified for the study
- •* Note: mixed gliomas are eligible, regardless of the degree of astrocytic or
- •oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q
- •- Patients with codeleted low grade gliomas must also be considered high risk by
- •exhibiting one or more of the following characteristics:
- •- Age >= 40 and any surgical therapy
- •- Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than
- •gross total resection)
- •- Documented growth following prior surgery (NOTE: patients with prior surgery
- •cannot have received prior radiation, chemotherapy or targeted therapy)
- •- Intractable seizures
- •- Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks
- •prior to registration; patient must have recovered adequately from the effects of
- •- Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to
- •registration
- •- Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration
- •- Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration
- •- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days
- •prior to registration
- •- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3
- •x ULN obtained =< 21 days prior to registration
- •- Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration
- •- Negative serum or urine pregnancy test done =< 7 days prior to registration, for women
排除标准
- •- The following categories are ineligible:
- •- Pregnant women
- •- Nursing women
- •- Men or women of childbearing potential who are unwilling to employ adequate
- •contraception or contraceptive method during this study and 6 months following
- •the completion of chemotherapy treatments
- •- History of prior radiation therapy or chemotherapy for glioma; note: patients who have
- •a history of prior low grade glioma (with or without a distant history of prior
- •surgery for that glioma), but who have never received prior chemotherapy or radiation
- •therapy for the glioma are eligible for the study
- •- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
- •of the investigator, would make the patient inappropriate for entry into this study or
- •interfere significantly with the proper assessment of safety and toxicity of the
- •prescribed regimens
- •- Concomitant serious immunocompromised status (other than that related to concomitant
- •steroids) that would compromise the safety of the patient on the study
- •- Patients known to be human immunodeficiency virus (HIV) positive and currently
- •receiving retroviral therapy are not eligible; note: patients known to be HIV
- •positive, but without clinical evidence of an immunocompromised state, are eligible
- •for the study
- •- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
- •infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
- •arrhythmia, or psychiatric illness/social situations that would limit compliance with
- •study requirements
- •- Receiving any other investigational agent that would be considered as a treatment for
- •the primary neoplasm
- •- Other active malignancy within 5 years of registration; exceptions: non-melanotic skin
- •cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior
- •malignancy, the patient is not eligible if they are receiving other specific treatment
- •(with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if
- •they have received prior total body irradiation which included the brain
- •- History of myocardial infarction =< 6 months, or congestive heart failure requiring
- •use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •- Recent history of hepatitis infection or if the treating physician determined that the
- •patient would be at significant risk of reactivation of hepatitis
研究者
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