JPRN-jRCTs031200099招募中3 期
JCOG1910: A Randomized Phase III Study of Short-Course Radiotherapy Combined with Temozolomide in Elderly Patients with Newly Diagnosed Glioblastoma - AgedGlio-PIII
ARAKAWA Yoshiki0 个研究点目标入组 264 人开始时间: 2020年8月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
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
- >= 71age old 至 ot applicable（—）
- 性别
- All
入选标准
- •First registration criteria
- •(1) Diagnosed as glioblastoma or Grade III glioma (WHO 2016 edition) in pathological diagnosis during surgery, or histologically proven diagnosis of glioblastoma by WHO 2016 criteria.
- •(2) Tumor specimen is available to analyze MGMT promoter methylation.
- •(3) No history of treatments for glioma except for resection including biopsy and the second resection within 21 days after the first resection (partly resection or biopsy).
- •(4) Within 21 days after surgery.
- •(5) The tumor exists supratentorial region on preoperative head contrast MRI.
- •(6) Preoperative head contrast MRI revealed no dissemination.
- •(7) Presence of measurable lesions is not mandatory.
- •(8) Patient' s age is 71 years or older at registration. Aged 71 to 75 years old with resection of less than 90% of contrast region.
- •(9) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
- •(10) No prior chemotherapy or head radiation therapy for any intracranial tumors.
- •(11) Sufficient organ function.
- •(i) Neutrophil count >= 1,500 /mm3
- •(ii) Hemoglobin >= 8.0 mg/dl
- •(iii) Platelet count >= 100,000 /mm3
- •(iv) AST =< 120 U/L
- •(v) ALT =< 120 U/L
- •(vi) Cr =< 1.605 mg/dL (male), =< 1.185 mg/dL (female)
- •(12) Written informed consent.
- •Second registration criteria
- •(1) Within 21 days of the first registration
- •(2) Histologically proven diagnosis of glioblastoma by WHO 2016 edition.
- •(3) Judged as methylation or unmethylation in MGMT promoter region.
排除标准
- •(1) Synchronous or metachronous (within 2 years) malignancies.
- •(2) Infections which needs systemic treatment.
- •(3) Body temperature is higher than 38 degrees centigrade at registration.
- •(4) Severe psychological disease.
- •(5) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
- •(6) Uncontrollable diabetes mellitus.
- •(7) Unstable angina pectoris, or history of myocardial infarction within 6 months.
- •(8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
- •(9) Gadolinium allergy.
- •(10) Positive HIV antibody.
- •(11) Positive HBs antigen.
研究者
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