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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Peking University People's Hospital
- Enrollment
- 339
- Locations
- 6
- Primary Endpoint
- Time To Disease free survival Event
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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?
Investigators
Jun Wang
Principal Investigator, Clinical Professor
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Time To Disease free survival Event
Time Frame: 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.
Secondary Outcomes
- 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)