JPRN-jRCTs031180215进行中（未招募）3 期
JCOG1016: Phase III randomized Study in patients with ANaplastic glioma of radiotherapy with Temozolomide versus nimustine hydrochloride (ACNU) followed by temozolomide - SANTA study (P-III)
MURAGAKI Yoshihiro0 个研究点目标入组 280 人开始时间: 2019年3月8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
- 280
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 <= 69age old（—）
- 性别
- All
入选标准
- •(1) Histologically proven anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma) or anaplastic ganglioglioma. For those who had additional surgery, he or she must meet (a) or (b).
- •(a) Diagnosed with anaplastic glioma after both primary and additional surgeries.
- •(b) Even if diagnosed with low grade glioma after primary surgery, diagnosed with anaplastic glioma after additional surgery.
- •(2) No history of previous therapy for tumor except craniotomy or biopsy (newly diagnosed tumor). Those who underwent additional surgery within 84 days after primary surgery are eligible.
- •(3) No history of carmustine implant or photodynamic therapy during the surgery.
- •(4) No clinically systemic metastasis (Imaging study except chest X-ray is not mandatory).
- •(5) More than 50% of tumor existing cerebrum and diencephalon.
- •(6) Preoperative MRI revealed no tumor recognized in the optic nerve, olfactory nerve and pituitary gland.
- •(7) Preoperative MRI revealed no multiple legions or dissemination.
- •(8) Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume under consultation with radiation oncologist.
- •(9) Preoperative and postoperative MRI revealed measurable or non-measurable disease.
- •(10) Three to 20 days after surgery.
- •(11) Aged 20 to 69 years old at registration.
- •(12) ECOG performance status (PS) of 0, 1, 2 or 3 due to neurological signs caused by the tumor.
- •(13) No prior chemotherapy or radiation therapy for any malignant diseases, but endocrine therapy for breast cancer or prostatic cancer is accepted.
- •(14) Adequate organ function.
- •(15) Tests for mutation of R132H on IDH1 gene by immunohistochemistry or PCR method is performed either from resected or biopsy samples.
- •(16) Written informed consent.
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
- •(2) Active infection requiring systemic therapy
- •(3) Active infectious meningitis requiring treatment
- •(4) Body temperature >= 38 degrees Celsius at registration
- •(5) Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
- •(6) Psychosis or with psychotic symptom
- •(7) Uncontrolled diabetes mellitus or routine administration of insulin
- •(8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
- •(9) Interstitial pneumonia, fibroid lung, or severe lung emphysema
- •(10) Gadolinium allergy
- •(11) Positive HIV antibody
- •(12) Potitive HBs antigen
研究者
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