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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Lobectomy plus Mediastinal Lymph Node Sampling

    Procedure/Surgery

    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.

  • Pulmonary Segmentectomy plus Mediastinal Lymph Node Sampling

    Procedure/Surgery

    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.

  • Pulmonary Wedge Resection plus Mediastinal Lymph Node Sampling

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Lobectomy GroupExperimental treatment 1 intervention
Group B: Segmentectomy GroupExperimental treatment 1 intervention
Group C: Wedge Resection GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 4 years after surgical resection

Secondary outcomes

1

Postoperative Major Complications Rate

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

Time frame
Within 90 days postoperatively

Other outcomes

1

Disease-Free Survival (DFS)

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

Time frame
Up to 4 years after surgery

Sponsors and contacts

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