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The investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer.
The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
Background
Hypothesis The investigators hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in patients with clinical stage IA non-small cell lung cancer.
Purpose The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
Study plan The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lobectomy | Lobectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm | ||
| Segmentectomy | Segmentectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm |
| |
| Wide wedge resection | Wide wedge resection will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extent of pulmonary resection | Procedure | Extent of pulmonary resection selected based on the institutional decision-making algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | the time from the date of the operation until the first recurrence or the last follow-up. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | the interval between the date of the operation and the date of death from any cause or the last follow-up | 5 years |
| Rate of loco-regional recurrence | Loco-regional recurrence means tumor recurrence within the ipsilateral hemithorax and mediastinum |
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Inclusion Criteria:
The following features should be fulfilled at preoperative thin-section CT scans
Clinical stage T1a-bN0M0 (according to 7th AJCC staging system)
Absence of proximal segmental or lobar bronchial involvement.
NSCLC must be confirmed in intraoperative frozen section biopsies or postoperative pathologic examinations if the lesion was not histologically confirmed before operation.
Age ≥ 18 years and < 75 years.
ECOG performance status 0-1.
The patient should have adequate cardiopulmonary reserve to tolerate lobectomy (ppo FEV1 > 40% and ppo DLCO > 40% or VO2 max > 15ml kg-1 min-1)
No prior chemotherapy or thoracic radiotherapy for any malignancy.
No prior malignancy within 5 years from study entry (except for non-melanoma skin cancer, superficial bladder cancer, thyroid cancer or carcinoma in situ of the uterine cervix).
The patient agrees to participate in the study and signs the informed consent form.
Exclusion Criteria:
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Patients who are planned to undergo surgery for clinical stage IA non-small cell lung cancer
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| Name | Affiliation | Role |
|---|---|---|
| Hong Kwan Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 5 years |
| Rate of systemic recurrence | Systemic recurrence means tumor recurrence outside the bilateral hemithorax or mediastinum except for lung-to-lung metastasis | 5 years |
| Postoperative FEV1 (Forced expiratory volume in 1 second; Liter) | the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. This value reflects the pulmonary function of participants | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date |
| Postoperative DLco (Diffusing capacity of the lung for carbon monoxide; mL/mmHg/min) | the extent to which oxygen passes from the air sacs of the lungs into the blood. This value is also related to the pulmonary function of participants | 6 months, 12 months, 24 months, 36 months, 48 months, 60 months after operation date |
| C/T ratio at thin section CT scans | C/T ratio is the consolidation/tumor ratio, which can be measured by the maximum diameter of consolidation to the maximum tumor diameter. Pathologic invasiveness of tumors can be predicted by this value. | within 2 months prior to operation date |
| Postoperative pathologic subtypes | (according to the 2015 WHO classification of lung tumors) | 1 month after operation date |
| Incidence of lymph node metastasis | The investigators will check the incidence of lymph node metastasis from the permanent pathology report. | within 1 month after operation date |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |