Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. The patients enrolled will be randomly allocated with 1:1:1 to three group: Control Group, standard-dose photon radiotherapy; Study Group A, standard-dose proton radiotherapy; Study Group B, standard-dose proton radiotherapy plus induction carbon-ion radiotherapy boost. The primary endpoint is overall survival (OS).
详细描述
This multi-center prospective phase 3 clinical trial will enroll 369 patients with newly diagnosed glioblastoma. Patients will be randomly allocated with 1:1:1 to three groups: Control Group, standard-dose photon radiotherapy (60 Gy); Study Group A, standard-dose proton radiotherapy (60 GyE); Study Group B, standard-dose proton radiotherapy (60 GyE) plus induction carbon-ion radiotherapy boost (15GyE/3F). All patients will receive concurrent and adjuvant temozolomide according to the Stupp protocol. The primary endpoint is overall survival (OS). The secondary endpoint is progression-free survival, side effect and quality life.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years old and <80 years old
- •Pathologically confirmed newly-diagnosed GBM
- •Redisual lesion after subtotal resection, partial resection, or biopsy
- •No dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion
- •ECOG score 0-1
- •Sign the informed consent form before starting the research
排除标准
- •No pathological confirmed evidence of GBM
- •Multiple lesions or distant spread indicated by imaging studies
- •Receive conventional photon/proton/carbon ion radiation therapy on the head
- •Received intracranial radioactive particle implantation
- •A history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma)
- •Positive pregnancy test for women of childbearing age
- •With the accompanying diseases or conditions affect the safety of patients during normal enrollment or research
- •Active mental disorders or other mental disorders that affect the patients ability to sign informed consent and understand
- •Uncontrolled active infection
结局指标
主要结局
Overall Survival
时间窗: From the pathological confirmation to death, a median of 3 years.
The interval from randomization to death
次要结局
- Progression-free Survival(From randomization to tumor progression, with a median of 3 years.)
- Toxicities(From start to 12 months after completion of radiotherapy.)
- Life Quality(From initiation of radiotherapy to 12 months after completion of radiotherapy.)
- Recognitive Function(From initiation of radiotherapy to 12 months after completion of radiotherapy.)
研究者
Jiade J. Lu
Professor
Shanghai Proton and Heavy Ion Center