MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients

Официальное название

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

Обзор

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.

Подробное описание

Background:

China faces a dual epidemiological trend of aging and increasing non-smoking-related lung cancer. Elderly patients (≥60 years) now constitute the majority of lung cancer cases but are often underrepresented in clinical trials. They present unique challenges including physiological decline, multiple comorbidities, and high heterogeneity, which cannot be adequately addressed by single-discipline decision-making. Multidisciplinary team (MDT) models have shown promise in improving outcomes, yet standardized geriatric-specific pathways remain lacking.

Objective:

To establish and validate an MDT-based umbrella decision-making model for elderly lung cancer patients, integrating comprehensive geriatric assessment (CGA) and individualized treatment planning across multiple therapeutic modalities.

Study Design:

This is a prospective, single-arm interventional study conducted at West China Hospital, Sichuan University. A historical control cohort (2014-2024) will be extracted from the hospital information system. Propensity score matching (1:1 to 1:2) will be applied to balance baseline characteristics including age, sex, TNM stage, pathology, ECOG score, and comorbidities.

Participants:

A total of 2,000 elderly patients (age 60-90 years) with histologically or cytologically confirmed lung cancer (stage I-IV) will be enrolled. Inclusion criteria also include ECOG PS 0-2, life expectancy ≥3 months, and written informed consent. Exclusion criteria include other active malignancies, severe cognitive impairment (MMSE \<20), contraindications to examinations, severe organ failure, and concurrent participation in other interventional trials.

Intervention:

All enrolled patients undergo MDT discussion involving thoracic surgery, geriatrics, respiratory medicine, oncology, rehabilitation, and radiology. The MDT formulates a personalized treatment plan based on tumor characteristics and CGA results (including nutritional, functional, and psychological status). Treatments may include:

1. Surgery (lobectomy, segmentectomy, wedge resection) 2. Ablation (radiofrequency, microwave, cryoablation) 3. Stereotactic body radiotherapy (SBRT) 4. Neoadjuvant immunochemotherapy 5. Medical oncology (chemotherapy, targeted therapy, immunotherapy) 6. Best supportive care and active surveillance

Standardized perioperative management and long-term follow-up (up to 5 years) are implemented. Follow-up assessments include imaging (CT, MRI, PET/CT as indicated), pulmonary function tests, quality of life questionnaires (EORTC QLQ-LC43), and adverse event monitoring.

Outcomes:

1. Primary outcome: 3-year progression-free survival (PFS) assessed by RECIST v1.1 2. Secondary outcomes: 1-, 3-, and 5-year overall survival (OS); objective response rate (ORR); disease control rate (DCR); quality of life changes; incidence and severity of adverse events (CTCAE v5.0); healthcare resource utilization

Statistical Analysis:

Analyses will be performed on full analysis set (FAS), per-protocol set (PPS), and safety set (SS). Survival curves will be estimated using Kaplan-Meier method and compared by log-rank test. Multivariable Cox regression will identify independent prognostic factors. Propensity score matching will be used to compare MDT group with historical controls. Missing data will be handled by multiple imputation.

Ethics and Dissemination:

The study protocol has been approved by the Ethics Committee of West China Hospital, Sichuan University (Approval No. 2287, 2025). The trial will be conducted in accordance with the Declaration of Helsinki and Chinese regulations. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publications and conference presentations.

Вмешательства

• Другое 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 individua

Первичные конечные точки

• 3-Year Progression-Free Survival (PFS) [Срок оценки: Up to 3 years]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: Up to 5 years]
• Disease-Free Survival (DFS) [Срок оценки: Up to 5 years]
• Objective Response Rate (ORR) [Срок оценки: Up to 5 years]
• Change in Quality of Life (EORTC QLQ-LC43) [Срок оценки: Up to 5 years]
• Healthcare Economic Outcomes [Срок оценки: Up to 5 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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.
• Estimated life expectancy ≥ 3 months.
• 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.
• Patients or their legal representatives provide written informed consent and commit to completing the full follow-up schedule (including questionnaires and functional assessments).
• Other conditions deemed suitable by the investigator.

Критерии исключения

• 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.
• 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.

• 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.
• 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%.
• Concurrent participation in another interventional clinical trial for lung cancer (observational studies are allowed).
• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT07509333 · Approval No. 2287 (2025)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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