Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years to 60 years
- •Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma
- •Karnofsky Performance Score ≥ 60
- •Adequate bone marrow, liver and renal function
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent
排除标准
- •Refusal to participate the study
- •Known hypersensitivity or contraindication to temozolomide
- •Previous irradiation, prior radiosurgery or prior chemotherapy
- •Pregnant or lactating females
- •Malignant tumor other than brain tumor
- •Contraindicated for MRI examination
- •Unable to comply with the follow-up studies of this trial
研究组 & 干预措施
Radiotherapy plus adjuvant temozolomide
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks. Four weeks after radiotherapy, patients will then receive 6 cycle of temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
干预措施: Radiotherapy (Radiation)
Radiotherapy plus adjuvant temozolomide
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks. Four weeks after radiotherapy, patients will then receive 6 cycle of temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
干预措施: Temozolomide (Drug)
Radiotherapy
Radiation therapy will start within 8 weeks after neurosurgical procedures. The residue gliomas will receive a total dose of 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: 5 years
次要结局
- Quality of life(5 years)
研究者
Zhongping Chen
Professor and Chair, Department of Neurosurgery
Sun Yat-sen University