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This multicenter prospective clinical study focuses on elderly patients with lung cancer. We will build a standardized clinical registry database, develop perioperative risk stratification and surgical early-warning models, optimize individualized surgical regimens, construct multidisciplinary perioperative comprehensive therapy, integrated Chinese-Western medicine full-cycle management and personalized postoperative rehabilitation systems, so as to form a whole-process optimized treatment model for elderly lung cancer.
This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lobectomy Group | Experimental | Patients receive standard lobectomy plus mediastinal lymph node sampling for early-stage non-small cell lung cancer, for elderly patients ≥65 years with T1N0M0 tumor. Postoperative standard perioperative management and regular follow-up are conducted. |
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| Segmentectomy Group | Experimental | Patients receive anatomic segmentectomy plus mediastinal lymph node sampling. All enrolled elderly patients are stratified by tumor size and preoperative geriatric risk score before randomization, followed by unified postoperative monitoring and adaptive perioperative treatment based on MRD and biomarker results. |
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| Wedge Resection Group | Experimental | Patients receive pulmonary wedge resection plus mediastinal lymph node sampling. After surgery, low-risk patients get de-escalated adaptive perioperative treatment guided by postoperative MRD surveillance, while high-risk patients receive individualized intensive comprehensive therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling | Procedure | Standard anatomical lobectomy combined with systematic mediastinal lymph node sampling for early-stage T1N0M0 non-small cell lung cancer in patients aged ≥65 years; postoperative stratified adaptive perioperative management guided by MRD and tumor biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from randomization to all-cause death, to compare long-term survival difference among lobectomy, segmentectomy and wedge resection groups in elderly early-stage lung cancer patients. | Up to 5 years after surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Major Complications Rate | Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies. | Within 90 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | Time from randomization to tumor recurrence or death; explore recurrence difference guided by postoperative MRD-based adaptive perioperative treatment. | Up to 5 years after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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This is a prospective parallel-group randomized controlled trial for elderly patients with early-stage lung cancer. Patients are stratified by tumor diameter and preoperative geriatric risk grading, then randomly assigned to different surgical resection arms (lobectomy, segmentectomy or wedge resection with lymph node sampling). Another parallel adaptive treatment cohort stratifies patients by postoperative recurrence risk based on MRD, gene and clinical biomarkers to receive individualized adjuvant de-escalated or standard perioperative treatment.
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Open-label trial; surgeons, patients and outcome assessors are not blinded to assigned surgical procedures and subsequent adaptive treatment regimens owing to different operation approaches and individualized treatment plans.
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| Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling | Procedure | Curative segmentectomy with mediastinal lymph node sampling after preoperative comprehensive geriatric risk assessment (CGA, VES-13, ASA grading); postoperative personalized perioperative treatment stratified by postoperative minimal residual disease status. |
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| Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling | Procedure | Wedge resection plus mediastinal lymph node sampling for eligible elderly early lung cancer patients; low-risk subjects receive de-escalated adaptive perioperative treatment, while high-risk patients receive intensified comprehensive therapy based on postoperative risk stratification. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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