Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Central Nervous System (CNS) Metastasis Versus Radiotherapy Alone
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 主要终点
- Number of Participants With Progression-free Survival (6 Month)
研究概览
简要总结
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior histologic confirmation of non-small cell lung cancer (NSCLC).
- •Optional: NSCLC histologic confirmation of metastasis of NSCLC.
- •Presence of unidimensionally measurable disease in the brain.
- •No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
- •Age: >18 years.
- •Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
- •Karnofsky Performance status >=70%.
- •Absolute neutrophil count (ANC) >1,500/mm^3, platelets >100,000/mm^3, hemoglobin >8 g/dL.
- •Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
- •Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <3 times upper limit of testing laboratory.
- •Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
- •Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
- •Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
- •Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
- •Written informed consent.
排除标准
- •Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
- •Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
- •Surgery within two weeks prior to temozolomide administration.
- •Recursive Partitioning Analysis (RPA) class III
- •Patients with a single brain metastasis amenable to radiosurgery of resection
- •Known Human Immunodeficiency Virus (HIV) disease.
- •Acute infection requiring intravenous antibiotics.
- •Any reason making compliance to the protocol improbable.
研究组 & 干预措施
Chemotherapy with temozolomide and radiotherapy
干预措施: Temozolomide and radiotherapy (Drug)
Radiotherapy alone
干预措施: Whole brain radiotherapy (Procedure)
结局指标
主要结局
Number of Participants With Progression-free Survival (6 Month)
时间窗: 6 months
The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as \<25% increase in tumor size on CT or MRI.
次要结局
未报告次要终点