NCT01351116已完成3 期
A Phase III, Multi-centre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High Dose Rate Intraluminal Brachytherapy
Ontario Clinical Oncology Group (OCOG)12 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 12
- 主要终点
- For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
研究概览
简要总结
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
详细描述
In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.
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
- •Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
- •Stages III, IV or recurrent disease
- •Documented endobronchial luminal disease by either endoscopy or CT-imaging
- •Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis
排除标准
- •Age less than 18 years of age
- •Uncontrolled or symptomatic brain metastases
- •Anticipated survival of less than 3 months
- •Systemic therapy planned to begin within 6 weeks following randomization
- •Systemic therapy within 4 weeks of planned study randomization
- •Any prior radiotherapy involving the lungs
- •Cardiac arrest or myocardial infarction within 6 months prior to study randomization
- •Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
- •Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
- •Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
- •Having received an investigational agent within one month of study randomization
- •Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility
结局指标
主要结局
For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
时间窗: 6 weeks from randomization
次要结局
- Improvement in each lung cancer symptom and overall symptoms at any time after randomization(at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization)
- Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100.(From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months)
- Overall survival, calculated from the date of randomization to the date of death(From date of randomization until the date of death from any cause assessed up to 48 months)
- Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization(6 weeks post randomization)
- A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50)(Weeks 3, 6, 12, 18, 26, 34, 42 and 50)
研究者
研究点 (12)
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