Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy
NCT ID: NCT02360761
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
339 participants
INTERVENTIONAL
2016-01-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lobectomy
Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).
VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Sublobar resection
Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Interventions
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VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Jun Wang
Principal Investigator, Clinical Professor
Principal Investigators
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Jun Wang, M.M.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Beijing Haidian Hospital
Beijing, , China
Peking university people's hospital
Beijing, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Sir Run Run Shaw Hospital
Hangzhao, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Fan Yang, M.D.
Role: CONTACT
Facility Contacts
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Yuqing Huang
Role: primary
Jun Wang, MD
Role: primary
Fenglei Yu
Role: primary
Zhoumiao Chen
Role: primary
Wenjie Jiao
Role: primary
Song Zhao
Role: primary
References
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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.
Other Identifiers
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CTONG1504
Identifier Type: -
Identifier Source: org_study_id
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