Iodine-125 Brachytherapy Together With Chemotherapy Compared With Surgical Resection Followed by Concomitant Radiochemotherapy in Patients With Newly Diagnosed Glioblastoma，a Randomized, Open-label, Multi-center Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
详细描述
This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.
The primary efficacy outcome was evaluated with progression-free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of glioblastoma confirmed by histology
- •Age: 18-75 years old
- •Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters
- •No prior anticancer therapy for glioblastoma besides biopsy.
- •ECOG PS：0-2 point
排除标准
- •Infra-tentorial tumor or tumor involves the ependymal surface.
- •Nonmeasurable disease.
- •Evidence of uncontrolled intracranial pressure.
- •Severe heart, brain, and lung diseases.
- •5.Severe hepatic or renal dysfunction.
- •Uncontrolled, active infection.
- •Severe clotting dysfunction.
- •Uncontrolled hypertension.
- •Participated in any other clinical treatment trial within 4 weeks before randomization.
- •Severe vascular diseases within 6 months before randomization.
- •Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.
研究组 & 干预措施
Iodine-125+Chemotherapy
Iodine-125; Temozolomide
干预措施: Iodine-125+Chemotherapy (Other)
Surgical resection+Radiochemotherapy
Surgical resection; Radiotherapy; Temozolomide:
干预措施: Surgical resection+Radiochemotherapy (Other)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 2.5 years after randomization
PFS is defined as the time from randomization to progression or death from any causes. Progression is defined as the RANO Criteria indicated.
次要结局
- Overall Survival (OS)(2.5 years after randomization)
- Survival rates at 6 months and 1 year(at 6 months and 1 year after operation respectively)
- EORTC QLQ-C30(2.5 year after randomization)
- ECOG Performance Status(2.5 year after randomization)
- Complications(within 1 week after operation)