VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer, a Multi-centre Randomised Controlled Trial With an Internal Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 9
- 主要终点
- Self-reported physical function using HRQoL questionnaire QLQ-C30
研究概览
简要总结
Lung cancer is the leading cause of cancer death worldwide and survival in the United Kingdom (UK) remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease and is traditionally undertaken via conventional open surgery. However, over the last decade there has been a surge in the number of minimal access resections performed using Video-assisted thoracoscopic surgery (VATS). However, there remains a need for well-designed and conducted randomised controlled trial (RCT) to provide the evidence base for the wide spread uptake and delivery of this surgical approach.
详细描述
The uptake of surgery for lung cancer in the UK is low and minimal access surgery may be regarded as a more acceptable intervention (compared to open surgery) by patients, referring respiratory physicians and oncologists. However, a large multi-centre RCT is essential to inform patient and clinician decision making and influence surgical practice in the UK.
The VIOLET study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer and will test the hypothesis that VATS surgery is superior to open surgery with respect to self-reported physical function five weeks after randomisation (approx. one month after surgery).
Specific objectives are to estimate:
A. The difference between groups in the average self-reported physical function at five weeks.
B. The difference between groups with respect to a range of secondary outcomes including assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pN2 disease and disease free survival) and overall survival.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥16 years of age
- •Able to give written consent, undergoing either:
- •i. Lobectomy or bilobectomy for treatment of known or suspected primary lung cancer beyond lobar orifice* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 or ii. Undergoing frozen section biopsy with the intention to proceed with lobectomy or bilobectomy if primary lung cancer with a peripheral tumour beyond a lobar orifice* in TNM8 stage cT1-3 (by size criteria, equivalent to TNM7 stage cT1a-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0-1 and M0 is confirmed
- •Disease suitable for both minimal access (VATS) and open surgery
排除标准
- •Adults lacking capacity to consent
- •Previous malignancy that influences life expectancy
- •Patients in whom a pneumonectomy, segmentectomy or non-anatomic resection (e.g. wedge resection) is planned
- •Patients with a serious concomitant disorder that would compromise patient safety during surgery.
- •Planned robotic surgery
研究组 & 干预措施
VATS lobectomy
VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802.
干预措施: Video Assisted Thoracoscopic Surgery (VATS) (Procedure)
Open lobectomy
Conventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers.
干预措施: Open Surgery (Procedure)
结局指标
主要结局
Self-reported physical function using HRQoL questionnaire QLQ-C30
时间窗: 5 weeks post randomisation
Physical functioning scale, ranges between 0 and 100. High score indicates high level of physical functioning.
次要结局
- Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post surgery(Proportion of patients upstaged to pN2 disease after surgical procedure, assessed up to 3 months post-surgery)
- Overall and disease-free survival to 1-year(1 year)
- Proportion of patients who undergo complete resection during the procedure, , assessed up to 12 months(Proportion of patients who undergo complete resection during the procedure, assessed up to 12 months)
- Disease-specific HRQoL - EORTC QLQ-C30 to 1-year(Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation)
- Resource use(Up to 1 year)
- Disease-specific HRQoL - EORTC QLQ-LC13 to 1-year(Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation)
- Generic HRQoL - EORTC EQ5D to 1-year(Measured at 2 week, 5 weeks, 3 months, 6 months and 1-year post randomisation)
- Time from surgery to hospital discharge, assessed up to 12 months(Time from surgery to hospital discharge, assessed up to 12 months)
- Adverse health events to 1 year(Adverse health events to 1 year)
- Proportion of patients taking up adjuvant treatment, assessed up to 12 months(Proportion and time to uptake of adjuvant treatment, assessed up to 12 months)
- Time to uptake of adjuvant treatment, assessed up to 12 months(Proportion and time to uptake of adjuvant treatment, assessed up to 12 months)
- Proportion of patients who experience prolonged incision pain (defined as the need of analgesia > 5 weeks post-randomisation)(Up to 1 year)