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NCT Number: NCT07632664

Clinical Study of a New Treatment Model for Elderly Lung Cancer Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Fan Yang, MD

CONTACT

[email protected]

010-88326650

About this study

This project consists of six interconnected research components around the whole-cycle management of elderly patients with lung cancer:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years old
  • Pathologically confirmed non-small cell lung cancer with clinical stage eligible for curative surgical resection
  • Complete preoperative geriatric comprehensive assessment data available
  • Capable of finishing planned surgery and long-term follow-up
  • Voluntarily sign informed consent form

Exclusion criteria

  • History of other malignant tumors within recent 5 years
  • Severe organic dysfunction of heart, liver, renal or respiratory system that cannot tolerate thoracic surgery
  • Preoperative confirmed distant metastasis preventing radical resection
  • Uncontrolled active severe infection or obvious coagulation disorders
  • Severe psychiatric disorder or cognitive dysfunction failing to cooperate with treatment and follow-up
  • Refuse random grouping and postoperative regular monitoring

Treatment and study plan

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.

Other names: Standard Radical Lung Resection

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.

Other names: Anatomic Sublobar Resection

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 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 outcomes

  1. Postoperative Major Complications Rate

    Time frame: Within 90 days postoperatively

    Incidence of grade ≥3 postoperative adverse complications within 90 days after surgery, comparing surgical safety across three resection strategies.

Other outcomes

  1. Disease-Free Survival (DFS)

    Time frame: Up to 4 years after surgery

    Time from randomization to tumor recurrence or death; explore recurrence difference guided by postoperative MRD-based adaptive perioperative treatment.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Multicenter Clinical Study on a New Treatment Model Combining New Surgical Techniques, Perioperative Comprehensive Treatment, and Postoperative Rehabilitation for Elderly Patients With Lung Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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