JPRN-jRCT1031190035进行中（未招募）3 期
JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy alone - MACS
KUMABE Toshihiro0 个研究点目标入组 250 人开始时间: 2019年6月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Suspicious as the primary glioblastoma on preoperative head contrast MRI.
- •(2) Judged that resection of more than 90% of contrast region on head contrast MRI can be achieved.
- •(3) No history of resection including biopsy for glioma. In case who diagnosed as glioblastoma after the first resection (partly resection or biopsy), all of the following conditions must be fulfilled:
- •(i) Resection of more than 90% of contrast region will be performed at the institutions in JCOG study groups of the Brain Tumor Study Group within 3 weeks from the first resection.
- •(ii) Preoperative head contrast MRI before first resection is available.
- •(iii) Negative of immunostaining of IDH1 if performed.
- •(4) The tumor exists in the cerebrum and diencephalon on preoperative head contrast MRI and no evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and pituitary gland.
- •(5) Preoperative head contrast MRI revealed no multiple legions or dissemination.
- •(6) Aged 20 to 75 years old at registration.
- •(7) ECOG performance status (PS) of 0, 1, 2, or 3 due to neurological signs caused by the tumor.
- •(8) No prior chemotherapy or head radiation therapy for any malignant diseases
- •(9) 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 =< 1.5 mg/dL
- •(10) Written informed consent.
- •Second registration (intraoperative) criteria
- •(1) Within 14 days of the first registration
- •(2) Diagnosed as glioblastoma or Grade III glioma (WHO 2016 edition) in pathological diagnosis during surgery.
- •(3) Judged as achievement of resection of more than 90% of the tumor. Intra MRI is not mandatory.
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) Female during pregnancy, within 28 days of postparturition, or during lactation.
- •(5) Severe psychological disease.
- •(6) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
- •(7) Uncontrollable diabetes mellitus.
- •(8) Unstable angina pectoris, or history of myocardial infarction within 6 months.
- •(9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
- •(10) Gadolinium allergy.
- •(11) Positive HIV antibody.
- •(12) Positive HBs antigen.
研究者
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