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RECRUITING

NCT07509333

MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Establishment and Validation of a Multidisciplinary Team (MDT)-Based Umbrella Decision-making and Treatment Model for Geriatric Lung Cancer Patients

Key Details

Gender

All

Age Range

60 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2025-12-01

Completion Date

2030-10-31

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Lung Neoplasms Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma Elderly

Interventions

OTHER

MDT-Based Umbrella Decision-Making Model

A structured multidisciplinary team (MDT) umbrella decision-making model for geriatric lung cancer patients. The MDT, comprising specialists from thoracic surgery, geriatrics, respiratory medicine, oncology, rehabilitation, and radiology, conducts comprehensive reviews of each patient's clinical data, including comprehensive geriatric assessment, tumor pathology, molecular profiling, and functional status. Based on this evaluation, the team formulates and oversees the implementation of individualized treatment plans across multiple therapeutic modalities (surgery, ablation, SBRT, targeted therapy, immunotherapy, etc.) and standardized follow-up protocols, tailored to distinct patient subgroups within the umbrella trial framework.

Inclusion Criteria: 1. Age 60 to 90 years. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). 3. Clinical stage I-IV (according to the 9th edition of the IASLC TNM staging system). 4. ECOG Performance Status 0-2. 5. Estimated life expectancy ≥ 3 months. 6. Able to tolerate baseline examinations (including CT, MRI, pulmonary function tests) and at least one planned treatment modality (surgery, ablation, SBRT, etc.) as assessed by the investigator. 7. Patients or their legal representatives provide written informed consent and commit to completing the full follow-up schedule (including questionnaires and functional assessments). 8. Other conditions deemed suitable by the investigator. Exclusion Criteria: 1. History of other primary malignancies within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix). 2. Unclear pathological diagnosis (no definite histologic or cytologic evidence) or post-enrollment pathological review excludes lung cancer. 3. 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. 4. Contraindications to study-related examinations or treatments: 4.1Known contraindication to iodine-based contrast agents or MRI (e.g., incompatible metallic implants). 4.2Known severe allergy to any of the essential therapeutic agents (e.g., chemotherapy, targeted drugs) involved in the study. 5. 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. 6. No fixed residential address or effective contact information, or family members refuse to assist with follow-up, leading to an estimated follow-up dropout risk \> 50%. 7. Concurrent participation in another interventional clinical trial for lung cancer (observational studies are allowed). 8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China