A Phase II, Open-label, Single-arm, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Whole-brain Radiotherapy With Concomitant Temozolomide in Lung Cancer and Breast Cancer Patients With Brain Metastases
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed lung cancer or breast cancer at primary site
- •Patient with inoperable brain metastases
- •Female or male, ≥ 20 and < 65 years of age
- •Karnofsky performance status (KPS) ≥ 70%
- •Life expectancy ≥ 12 weeks
- •Adequate organ function
- •Willing and able to provide a written informed consent
排除标准
- •Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
- •Male whose partner is planning to be pregnant
- •Inability to swallow
- •Meningeal carcinomatosis
- •History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
- •Prior use of temozolomide
- •Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
- •Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
- •Current use of valproic acid
- •Use of any investigational product within 4 weeks prior to the initiation of study treatment
- •Patient with any condition or disease which is considered not suitable for this study by investigator
研究组 & 干预措施
temozolomide+WBRT
temozolomide: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks WBRT:30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week)
干预措施: temozolomide 100mg (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.
次要结局
- Progression free survival (PFS)(assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.)