Determination of the Toxicity of Standard Dose Cetuximab Together With Concurrent Individualised, Isotoxic Accelerated Radiotherapy and Cisplatin-vinorelbine for Patients With Stage III Non-small Cell Lung Cancer: A Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) 3 months after the ende of chemo-radiation
研究概览
简要总结
To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine
详细描述
Phase I trial with escalating doses of vinorelbine and standard doses of radiotherapy, cisplatin and cetuximab.
Eligible patients receive 2 cycles of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. One cycle duration is 21 days.
Patients without progressive disease (PD) according to the RECIST criteria (appendix 1) will be entered in the phase I dose-escalation part of the study. Chest radiation is given concurrently with cetuximab, cisplatin and vinorelbine. The latter drug will be escalated in three steps until dose-limiting toxicity occurs.
On day 43, i.e. 14 days after the last gemcitabine delivery, radiotherapy is started.
Radiotherapy: In all patients in every dose-step, the radiation will be given as follows: first 3 weeks: 1.5 Gy BID to a dose of 45 Gy in 30 fractions, then 2 Gy QD to a mean lung dose (MLD, this is related to radiation-induced lung damage) of 19 Gy. Maximum dose: 69 Gy given in 5.5 weeks. Maximum dose to the spinal cord: 50 Gy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer
- •Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion)
- •WHO performance status 0 or 1
- •Less than 10% weight loss in the last 6 months
- •Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value
- •No recent severe cardiac disease
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate hepatic function
- •Life expectancy more than 6 months
- •Measurable cancer
- •Willing and able to comply with study prescriptions
- •18 years or older
- •Not pregnant or breast feeding
- •Written informed consent
- •No previous radiotherapy to the chest
排除标准
- •Not non-small cell lung cancer histology
- •Mixed pathology
- •History of prior chest radiotherapy
- •Recent (<3 months) myocardial infarction
- •Uncontrolled infectious disease
- •Less than 18 years old
- •Inadequate pulmonary function
- •Other active malignancy
结局指标
主要结局
Maximum Tolerated Dose (MTD) 3 months after the ende of chemo-radiation
时间窗: 3 months
次要结局
- During and after chemo-radiation: (CTC 3.0) Dysphagia, Cough, Dyspnea, Skin rash, Myelitis, Neuropathy, Neutrophiles, Platelets, Hemoglobin, Diarrhea, Renal failure, Liver dysfunction, Tumour response 3 m. after end chemo-radiation and Survival(3 months)