Health Trials

About this trial

This is a single-center, prospective, single-arm interventional study with historical control, designed to evaluate the clinical value of a multidisciplinary team (MDT)-based decision-making umbrella decision model in elderly patients with lung cancer. A total of 2,000 patients aged 60-90 years with newly diagnosed non-small cell or small cell lung cancer will be enrolled. Each patient will undergo comprehensive geriatric assessment and receive an individualized treatment plan formulated by an MDT comprising thoracic surgeons, geriatricians, oncologists, pulmonologists, rehabilitation therapists, and radiologists. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. The primary outcome is 3-year progression-free survival (PFS). Secondary outcomes include overall survival, objective response rate, quality of life (EORTC QLQ-LC43), incidence of adverse events (CTCAE v5.0), and healthcare economics. Historical controls (2014-2024) will be extracted from hospital records and matched using propensity score matching. The study aims to establish a standardized MDT pathway to improve treatment outcomes and reduce risks in the geriatric lung cancer population.

Eligibility criteria

Qualifiers

Age 60 to 90 years.

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Clinical stage I-IV (according to the 9th edition of the IASLC TNM staging system).

ECOG Performance Status 0-2.

Disqualifiers

History of other primary malignancies within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).

Unclear pathological diagnosis (no definite histologic or cytologic evidence) or post-enrollment pathological review excludes lung cancer.

Severe psychiatric disorders (e.g., Alzheimer's disease, schizophrenia) or cognitive impairment (MMSE score < 20) that interferes with questionnaire completion or treatment decision-making communication.

Severe organ dysfunction (e.g., Child-Pugh class C cirrhosis, end-stage renal disease without dialysis) that precludes tolerability of baseline examinations or any treatment.

Trial design

Treatments tested in this trial

  • MDT-Based Umbrella Decision-Making Model

Treatment groups

2,000 Participants
are divided into 1 treatment group

Locations

1
West China Hospital, Sichuan University610041, ChengduSichuan, China

Sponsors and collaborators

West China Hospital

Lead sponsor

Source ClinicalTrials.gov