Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.
详细描述
Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 46 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •At leat one brain metastasis MRI
- •KPS 70 or more
- •RTOG-RPA I or II
- •Basic Laboratory requirements
排除标准
- •Candidates for radiosurgery, neurosurgery
- •Patients treated with radiotherapy before entered to the study
研究组 & 干预措施
Chloroquine, radiosensitizer
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.
干预措施: Chloroquine (Drug)
Chloroquine, radiosensitizer
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.
干预措施: Total brain radiotherapy (Radiation)
Placebo
30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days
干预措施: Total brain radiotherapy (Radiation)
结局指标
主要结局
Overall Response Rate
时间窗: Every third month after randomization until 24 months follow-up. Measured by brain MRI
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria
次要结局
- Central Nervous System Progression Free Survival(From time to progression to 24 months follow up)
研究者
Oscar Gerardo Arrieta Rodríguez
Principal Investigator
Instituto Nacional de Cancerologia de Mexico