Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment.
研究概览
简要总结
To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Able to give informed written consent in the English language
- •Able and willing to attend St Georges Hospital / Royal Marsden Hospital for stent insertion (if allocated) and documentation of 6 minute walking distance.
- •Willing to re-attend for follow-up and 6 minute walking distance at St Georges Hospital / Royal Marsden Hospital 2 weeks later (all patients)
- •Diagnosis of non-small cell lung cancer with centrally placed tumour with some degree of airway obstruction from information from bronchoscopy or CT scan.
- •ECOG Performance status: 0-3
排除标准
- •Relative contraindications to stenting, e.g. bleeding abnormality or anticoagulation problems.
- •Pregnancy
- •Radically treatable disease.
研究组 & 干预措施
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Arterial puncture (Other)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Venepuncture (Other)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: General anaesthetic (Procedure)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Inpatient stays (Procedure)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Walking test (Other)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Spirometry & flow volume loop assessment (Other)
Treatment Arm A
Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control
干预措施: Biopsy material (Other)
Treatment Arm B
Standard palliative treatment and standard dyspnoea symptom control.
干预措施: Arterial puncture (Other)
Treatment Arm B
Standard palliative treatment and standard dyspnoea symptom control.
干预措施: Venepuncture (Other)
Treatment Arm B
Standard palliative treatment and standard dyspnoea symptom control.
干预措施: Walking test (Other)
Treatment Arm B
Standard palliative treatment and standard dyspnoea symptom control.
干预措施: Spirometry & flow volume loop assessment (Other)
结局指标
主要结局
The primary endpoint of the study is the proportion of patients achieving a 50% improvement in the distance walked after 2 weeks +/- 2 days of treatment as compared to their pre-treatment assessment.
次要结局
- To compare arterial blood gases (oxygenation of blood) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
- To compare lung function tests from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group.
- To compare other symptoms such as anxiety and breathlessness, as measured by standard scales (e.g. VAS, Borg scales) from baseline to 2 weeks +/- 2 days in the stented group, compared with the standard treatment group
- To measure quality of life with standard questionnaires
- To compare survival rates at 6 months and 1 year between the stented group and standard treatment group
- To document any subsequent treatments given to patients in each group
- To establish the feasibility of collecting fresh and formalin fixed, paraffin embedded tumour and normal bronchial tissue, and germ-line DNA for future research into NSCLC carcinogenesis and corollary translational work
- Formal objective response assessment is not required at 3 months, but where this is possible, this will be described