NCT04574856进行中（未招募）2 期
A Phase II Study of Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 12-month overall survival rate
研究概览
简要总结
This study will investigate whether or not intensified radiation therapy adapted during the radiation treatment course to high-risk, treatment-resistant tumor regions will improve overall survival in patients with newly diagnosed glioblastoma (GBM) compared to conventional chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
- •Karnofsky performance status >=70
- •Minimal life expectancy of 12 weeks
- •Adequate bone marrow reserve (Hemoglobin ≥ 10 g/dL, absolute neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3), acceptable liver function (total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), and ALT/AST ≤ 5 x ULN) and renal function (serum creatinine ≤ 2.0 mg/dL) within 14 day prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
- •Maximal contiguous diameter of tumor based on high b-value diffusion MRI and DCE perfusion MRI ≤5 cm
- •Patients must be registered within 6 weeks of most recent resection
- •Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment and study participation.
排除标准
- •Recurrent glioma, or tumor involving the brainstem or cerebellum
- •Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is >3 years.
- •Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination)
- •Evidence of severe concurrent disease requiring treatment
- •Prior invasive malignancy (except non-melanoma skin cancer or non-life limiting invasive malignancy that may not require treatment, such as low-risk prostate cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
- •Patients unable to undergo MRI exams (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses [e.g. pins in artificial joints and surgical pins/clips], or unable to receive gadolinium for MRI, as per the standard Department of Radiology MRI screening criteria)
- •Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap as determined by treating physician
- •Multifocal disease (>1 lobe of involvement) of discontiguous contrast enhancing disease as seen on conventional MRI
- •Pregnancy or lactation
研究组 & 干预措施
Patients with Newly Diagnosed Glioblastoma
Experimental
Patients will receive dose-intensified, adaptive photon radiation therapy
干预措施: Dose-Intensified Radiotherapy (Radiation)
Patients with Newly Diagnosed Glioblastoma
Experimental
Patients will receive dose-intensified, adaptive photon radiation therapy
干预措施: Temozolomide (Drug)
Patients with Newly Diagnosed Glioblastoma
Experimental
Patients will receive dose-intensified, adaptive photon radiation therapy
干预措施: Adjuvant temozolomide (Drug)
结局指标
主要结局
12-month overall survival rate
时间窗: 12 months post radiation therapy (RT)
12-month overall survival rate of study participants (failure defined as death due to any cause)
次要结局
- Advanced MRI Gross tumor volume (GTV) and its association with overall survival(3 months post-RT)
- Patient-reported quality of life (QOL) using EORTC QLQ-C30 and BN20(Up to 12 months post-RT)
- Patient objective neurocognitive function(Up to 12 months post-RT)
- Overall survival(2 years)
- Progression-free survival rate(2 years)
- Proportion of failures classified by relation to the high-dose radiation region(2 years)
- Patient-reported symptom burden using MDASI-BT(Up to 12 months post-RT)
- Grade 3 or higher treatment-related toxicities(12 months post-RT)
研究者
研究点 (1)
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