Concomitant Radiotherapy and Erlotinib in Advanced Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
研究概览
简要总结
The purpose of this study is to determine if erlotinib given orally along with concurrent palliative irradiation to lung cancer improves local control compared to those treated with radiotherapy alone.
详细描述
Endpoints:
Primary:
- To determine if erlotinib given orally along with concurrent external beam radiation therapy, prolongs local tumour control as determined by CT evaluation compared to treatment with external beam radiation therapy alone
Secondary:
- To confirm the safety profile of erlotinib along with concurrent external beam radiation therapy.
- To evaluate if erlotinib along with concurrent external beam radiation therapy, improve quality of life as assessed with the EORTC QLQ-C30 and the EORTC QLQ-LC13.
- To evaluate if PET-CT examination can be used to predict response to treatment.
- To evaluate overall survival in the different groups
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
- •Age >18 years
- •Histological or cytological verified NSCLC
- •Palliative radiotherapy to thorax indicated
- •ECOG Performance status 0-2
- •Fertile patients must use contraception
- •Signed informed consent
- •Ability to understand and fill in QoL questionnaires
- •Capability to take per os medication
- •Serum bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
- •Creatinine < 5 times ULN
排除标准
- •Pregnancy or nursing
- •Other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
- •No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
- •No prior radiotherapy to the same organ / place
- •No concurrent treatment with other experimental drugs
- •Known brain metastases in need of radiotherapy
- •Known hypersensitivity to erlotinib or other substances in the erlotinib tablets.
研究组 & 干预措施
Radiotherapy alone
Radiotherapy 3 Gy x 10 alone
干预措施: Radiation (Radiation)
Radiotherapy combined with erlotinib
Standard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
干预措施: Erlotinib (Drug)
Radiotherapy combined with erlotinib
Standard treatment 3 Gy x 10 to lung tumor and mediastinal lymph nodes and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.
干预措施: Radiation (Radiation)
结局指标
主要结局
Number of patients with progression in radiation field among patients treated with erlotinib combined with radiotherapy compared to radiotherapy alone
时间窗: 1 year
Evaluate local control by radiological evaluation
次要结局
- Overall survival will be measured(1 year)
- Number of Participants With Treatment-Related Adverse Events grade >3 as Assessed by CTCAE v4.0(1 year)
研究者
Åslaug Helland
MD PhD
Oslo University Hospital