Aged, Lung Neoplasm, Perioperative Care, Postoperative Rehabilitation, Thoracic Surgical Procedures
Conditions
Keywords
Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery
Brief summary
This multicenter prospective clinical study focuses on elderly patients with lung cancer. The investigators 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.
Detailed description
This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer: 1. Construction of multicenter prospective cohort and clinical registry database for elderly lung cancer The investigators will launch a prospective multicenter cohort study covering no less than 30 clinical centers and enrolling over 2000 elderly lung cancer patients to build a full-process clinical database. Core recorded indicators include comprehensive geriatric assessment, postoperative complications, overall survival, treatment-related adverse events and disease-free survival after recurrence. 2. Development and external validation of prognostic risk stratification and surgical safety early-warning system Based on existing geriatric disease data, the investigators integrate multi-dimensional data including comprehensive geriatric status, comorbidities, imaging, pathology and molecular biomarkers to construct and iteratively optimize predictive models for surgical safety and long-term prognosis. The established risk stratification and early-warning system will be further validated using prospective multicenter cohort data. 3. Establishment and validation of optimized surgical strategy for elderly lung cancer By prospective multicenter clinical trial design, the investigators compare long-term survival outcomes among radical resection, precision limited resection and palliative resection guided by preoperative risk stratification system, so as to formulate evidence-based optimized surgical selection framework for elderly early-stage lung cancer patients. 4. Development and validation of standardized perioperative comprehensive treatment strategy Relying on previous perioperative research data, multidisciplinary team is organized to establish adaptive perioperative comprehensive treatment guided by clinical characteristics, gene variation status and minimal residual tumor monitoring; meanwhile, a unified evaluation standard system for this comprehensive treatment mode will be constructed and verified. 5. Construction and validation of full-cycle collaborative management system combining traditional Chinese and western medicine The investigators explore the evolution law of clinical symptom clusters and TCM deficiency syndrome across perioperative stages of elderly lung cancer, screen evidence-based traditional Chinese medicine intervention measures for different treatment phases, and establish and verify the full-cycle collaborative treatment system integrated western routine therapy and individualized Chinese herbal intervention. 6. Development and verification of individualized postoperative adaptive rehabilitation model With physical function, psychological status and nutritional level as core evaluation indicators, multidisciplinary rehabilitation team is set up to tailor personalized rehabilitation protocols for postoperative elderly patients. Combined with remote real-time monitoring and instant intervention intelligent platform, a novel adaptive postoperative rehabilitation model is built and prospectively validated in clinical practice.
Interventions
PROCEDUREPulmonary Lobectomy plus Mediastinal Lymph Node Sampling
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.
PROCEDUREPulmonary Segmentectomy plus Mediastinal Lymph Node Sampling
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.
PROCEDUREPulmonary Wedge Resection plus Mediastinal Lymph Node Sampling
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥65 years old 2. Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection 3. Complete preoperative geriatric comprehensive assessment data available 4. Capable of finishing planned surgery and long-term follow-up 5. Voluntarily sign informed consent form
Exclusion criteria
1. History of other malignant tumors within recent 5 years 2. Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery 3. Preoperative confirmed distant metastasis preventing radical resection 4. Uncontrolled active severe infection or obvious coagulation disorders 5. Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up 6. Refuse random grouping and postoperative regular monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 4 years after surgical resection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Major Complications Rate | Within 90 days postoperatively | Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies. |
Countries
China
Outcome results
None listed