Phase II Randomized Study: Whole Brain Radiotherapy and Concomitant Temozolomide, Compared With Whole Brain Radiotherapy for Brain Metastases Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective Response Rates. Assessed With Cranial MRI
研究概览
简要总结
RATIONALE
- Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.
PURPOSE
- This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.
详细描述
Primary Outcome Measures
- Objective Response Rates
Secondary Outcome Measures
- Survival Free of Brain Metastases progression
- Overall Survival
- Systemic Side effects
Objectives
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
- •Karnofsky performance status (KPS) ≥ 50
- •Life expectancy ≥ 12 weeks
- •Histologically confirmed non lymphomatous solid tumors at primary site
- •Brain metastases diagnosed with cranial MRI/CT.
- •Extracranial metastases or primary tumor uncontrolled are allowed
- •Hemoglobin ≥ 10 g/dl
- •Absolute neutrophil count of > 1500/mm3
- •Platelet count of ≥ 100,000/mm3
- •Blood urea nitrogen (BUN) ≤ 25 mg/dl,
- •Serum creatinin ≤ 1.5 mg/dl
- •Serum bilirubins ≤ 1.5 mg/dl,
- •Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ twice the upper normal limit
- •Exclusion Criteria
- •Pregnant or breast feeding woman
- •History of allergic reaction to iodinated contrast media
- •Inability to swallow
- •Systemic chemotherapy in previous 3 weeks
- •Oral chemotherapy in previous 2 weeks
- •Prior surgery, chemotherapy, or radiotherapy for a brain neoplasm
- •Meningeal carcinomatosis
排除标准
- 未提供
研究组 & 干预措施
Whole brain irradiation plus Temozolomide
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
干预措施: Temozolomide (Drug)
Whole brain irradiation plus Temozolomide
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
干预措施: Whole brain irradiation (Radiation)
Whole brain irradiation
Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
干预措施: Whole brain irradiation (Radiation)
结局指标
主要结局
Objective Response Rates. Assessed With Cranial MRI
时间窗: 90 days
Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI. Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants.
次要结局
- Survival Free of Brain Metastases Progression (PFS of BM)(at 90 days)
- Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.(4 months)
- Overall Survival(1 year)
研究者
Carlos Gamboa Vignolle
Radiation Oncologist
Instituto Nacional de Cancerologia de Mexico