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

NCT07632664 | Recruiting DMC

• 1 other identifier: 2023ZD0501700
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Neoplasm; Thoracic Surgical Procedures; Perioperative Care; Postoperative Rehabilitation; Aged

Keywords

Elderly lung cancer, Risk stratification, Multimodality therapy, Integrated Chinese and Western Medicine, Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative Major Complications Rate

  Within 90 days postoperatively

Other Outcomes (1)

• Disease-Free Survival (DFS)

  Up to 5 years after surgery

Study Arms (3)

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.

Procedure: Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling

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.

Procedure: Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling

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.

Procedure: Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling

Interventions

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.

Also known as: Standard Radical Lung Resection

Lobectomy Group

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.

Also known as: Anatomic Sublobar Resection

Segmentectomy Group

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.

Wedge Resection Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)