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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lobectomy | Active Comparator | Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS). |
|
| Sublobar resection | Experimental | Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS | Procedure | Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time To Disease free survival Event | The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Perioperative Complication and Death as a Measure of Safety. | Perioperative complication is defined as the complication occurred after surgery and before discharge, or within 30 days postoperatively. Death cases during this period should be recorded as perioperative death. | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly. | The scores of prospective CGA and 4-yr mortality index to predict the outcome of the elderly. | 3 years |
| The total cost as a measure of the cost/benefit analysis |
Inclusion Criteria:
Aged 70 years or older
Preoperative criteria (contrast-enhanced Computed tomography scan)
Intraoperative criteria
General criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Wang, M.M. | Contact | +8601088326650 | Jwangmd@yahoo.com | |
| Fan Yang, M.D. | Contact | +86010883266557 |
| Name | Affiliation | Role |
|---|---|---|
| Jun Wang, M.M. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Haidian Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27053091 | Derived | 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. |
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|
| Thoracotomy | Procedure | Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy. |
|
|
| Hospitalization time after surgery in Participants |
Defined as the time interval from the day of operation to discharge. |
| 1 months |
| Intubation time after surgery in Participants | Defined as the time interval from the day of operation to extubation. | 1 months |
| Time To Overall survival Event | The time interval from randomization to death from any cause. | 3 years |
| Percentage of Participants With Local Recurrence and Metastasis Event | The ratio of local recurrence and metastasis in 3 years from the day of randomization | 3 years |
| Postoperative pulmonary function | The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization. | 3 years |
| Percentage of Participants With VATS procedure | The ratio of video assisted thoracoscopic surgery in each group. | 1 month |
| Scores on the quality of life questionaires | The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization. | 3 years |
The cost/benefit analysis of sublobar resection versus lobectomy |
| 3 years |
| The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5 | The radiologic character of C/T>0.5 has been considered as a pathologically noninvasive lung cancer. and the rate of pathologically noninvasive lung cancer will be used as a measure for the relation between the radiologic / pathologic character of primary non-small-cell lung cancer and prognosis. | 1 month |
| The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability. | The morbidity rate after surgery for participants who underwent video-assisted thoracoscopic or open procedures a Measure of Safety and Tolerability. | 3 years |
| Peking university people's hospital | Recruiting | Beijing | China |
|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | China |
|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhao | China |
|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| D013906 | Thoracoscopy |
| D013908 | Thoracotomy |
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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