Clinical trial NCT02360761: Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer;Elderly;Sublobar resection;Lobectomy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 339
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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
* 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

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

Primary outcomes:
measure: Time To Disease free survival Event
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
timeFrame: 1 months
measure: Hospitalization time after surgery in Participants
timeFrame: 1 months
measure: Intubation time after surgery in Participants
timeFrame: 1 months
measure: Time To Overall survival Event
timeFrame: 3 years
measure: Percentage of Participants With Local Recurrence and Metastasis Event
timeFrame: 3 years
measure: Postoperative pulmonary function
timeFrame: 3 years
measure: Percentage of Participants With VATS procedure
timeFrame: 1 month
measure: Scores on the quality of life questionaires
timeFrame: 3 years
Other outcomes:
measure: The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.
timeFrame: 3 years
measure: The total cost as a measure of the cost/benefit analysis
timeFrame: 3 years
measure: The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5
timeFrame: 1 month
measure: The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability.
timeFrame: 3 years
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital
city: Beijing
country: China
facility: Peking university people's hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Hangzhao
country: China
facility: Sir Run Run Shaw Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang F, Sui X, Chen X, Zhang L, Wang X, Wang S, Wang J. Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial. Trials. 2016 Apr 7;17:191. doi: 10.1186/s13063-016-1312-6.