NCT00115518已完成2 期
Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
研究概览
简要总结
The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).
Endpoints:
safety and feasibility (primary) response, survival, time to progression (secondary)
详细描述
Study entry examinations:
- blood cell count
- liver enzymes
- ventilatory function test
- pregnancy test (premenopausal women)
- CT of the thorax
- CT of the brain
- Ultrasound of the liver
- Bone scan
- FDG PET scan (after inclusion)
Follow-up examinations (2 months, than every 3 months):
- patients history and examination
- CT scan of the thorax
- ventilatory functions test
- FDG PET scan (at least at 6 months)
- bone scan (yearly)
- ultrasound of the liver (every 6 months)
Cetuximab administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically verified NSCLC
- •Not eligible for Radiochemotherapy or patient refuses chemotherapy
- •FeV1 >1.5 L or min. 50%
- •KPI >= 70%
- •Life expectancy > 6 months
- •Weight loss less than 10% of body weight in 12 months
- •Compliance
- •Adequate blood counts (LC > 3000 x 10^3/ml, Tc >100000 x 10^3/ml, Hb > 10 g/dl)
- •Effective contraception
- •Amendment 1/07: FeV1 >1.2 L or min 40%
排除标准
- •Active infection
- •Reduced liver function
- •Vena cava superior syndrome
- •Malignant pleural effusion
- •Pregnancy or breast feeding
- •Additional serious systemic disease
- •Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for > 5 years)
- •Known allergies against proteins
- •History of former antibody therapy
- •Allergy against i.v. contrast agents
结局指标
主要结局
safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
时间窗: 3 yrs
次要结局
- response (RECIST criteria of primary tumor and enlarged lymphnodes)(3 yrs)
- survival (at 3 years)(3 yrs)
- time to progression (locally and systemically)(3 yrs)
研究者
研究点 (2)
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