Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 339
- 试验地点
- 6
- 主要终点
- Time To Disease free survival Event
研究概览
简要总结
The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.
详细描述
This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 70 years or older
- •Preoperative criteria (contrast-enhanced Computed tomography scan)
- •Suspected non-small cell lung cancer
- •Clinical stage ⅠA, i.e. T1N0M0 (tumor diameter ≤3 cm, surrounded by visceral pleura, short-axis of lymph node <1 cm or cold lymph nodes on PET scan)
- •The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions
- •Eligible for sublobar resection with sufficient margin
- •Intraoperative criteria
- •Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasive adenocarcinomas defined by The International Association for the Study of Lung Cancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)
- •Pathological exclusion of suspected lymph nodes involvement
- •Feasible to perform sublobar resection in terms of surgical margin requirement
- •General criteria
- •Must sign informed consent by the patient or his/her entrusted party
- •Must complete 4-year mortality index and comprehensive geriatric assessment(CGA) if necessary
- •The physiological reservation can tolerate lobectomy
排除标准
- •Unable to comply with the study procedure
- •Past thoracic surgery history, except for diagnostic thoracoscopy
- •Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ
- •Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases
- •Uncontrollable infections
- •Coexisting small cell lung cancer
- •Psychiatric diseases diagnosed
- •Other circumstances which is deemed inappropriate for enrollment by the researchers
结局指标
主要结局
Time To Disease free survival Event
时间窗: 3 years
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
次要结局
- Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.(1 months)
- Hospitalization time after surgery in Participants(1 months)
- Intubation time after surgery in Participants(1 months)
- Percentage of Participants With Local Recurrence and Metastasis Event(3 years)
- Time To Overall survival Event(3 years)
- Postoperative pulmonary function(3 years)
- Percentage of Participants With VATS procedure(1 month)
- Scores on the quality of life questionaires(3 years)
研究者
Jun Wang
Principal Investigator, Clinical Professor
Peking University People's Hospital