Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Small Cell Lung Carcinoma
Conditions
Keywords
Lung cancer, Elderly, Geriatric, Multidisciplinary team, Umbrella trial
Brief 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.
Detailed description
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. The primary historical comparison will use patients treated during the most recent pre-implementation period (2021-2024) to reduce differences in staging, imaging, molecular testing, and access to targeted and immunotherapies. Patients treated during 2014-2020 will be included only in era-stratified sensitivity analyses. 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 prospective study protocol has been approved by the Ethics Committee of West China Hospital, Sichuan University (Approval No. 1773, 2025). The use of retrospective medical record data from 2014 to 2024 has been separately approved by the same Ethics Committee (Approval No. 2287, 2025). Written informed consent will be obtained from all prospectively enrolled participants, while the consent requirements for the retrospective cohort will be handled in accordance with the corresponding ethics approval. The study will be conducted in accordance with the Declaration of Helsinki and applicable Chinese regulations. Results will be disseminated through peer-reviewed publications and conference presentations. Safety Monitoring： An independent data monitoring committee is not planned because the study evaluates a CGA-informed MDT care pathway and does not mandate the use of an investigational drug or device. All specific anticancer treatments will be delivered according to routine clinical practice and applicable treatment guidelines.Adverse events will be identified and managed by the treating clinical team. Serious adverse events will be reported to the principal investigator within 24 hours after awareness and reported to the Ethics Committee in accordance with institutional requirements.A study safety monitoring group comprising investigators from relevant clinical disciplines will review serious adverse events, grade 3 or higher treatment-related adverse events, unexpected study-related risks, and major protocol deviations at prespecified intervals. The group may recommend protocol modification, additional participant protection measures, or temporary suspension of study-specific procedures when necessary.
Interventions
OTHERMDT-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, results of clinically indicated tumor somatic molecular testing when available, 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.
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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 another active primary malignancy within the previous 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ, or another malignancy considered unlikely to affect the study outcomes. 2. Lung cancer cannot be confirmed by histologic or cytologic examination. 3. A medical emergency requiring immediate treatment that precludes completion of the baseline study procedures and MDT review before treatment initiation. 4. Cognitive or communication impairment that prevents completion of the core study procedures when no legally authorized representative or appropriate proxy assistance is available. 5. A contraindication to all clinically acceptable methods required for the core study-specific baseline assessment, with no suitable alternative assessment available. 6. Concurrent participation in another interventional study that mandates a treatment strategy incompatible with the CGA-informed MDT care pathway. 7. Any condition that makes the study-specific assessment procedures unsafe, provided that the reason for exclusion is documented by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Progression-Free Survival (PFS) | Up to 3 years | Progression-free survival is defined as the time from the start of initial treatment to the first occurrence of disease progression (assessed by RECIST version 1.1 criteria) or death from any cause, whichever occurs first. The 3-year PFS rate will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 5 years | Overall survival is defined as the time from the start of initial treatment to death from any cause. OS rates at 1, 3, and 5 years will be estimated. |
| Disease-Free Survival (DFS) | Up to 5 years | Disease-free survival is defined as the time from curative-intent treatment (e.g., surgery, SBRT, ablation) to first recurrence or death from any cause, whichever occurs first. DFS rates at 1, 3, and 5 years will be reported for patients receiving curative-intent therapy. |
| Objective Response Rate (ORR) | Up to 5 years | ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). |
| Change in Quality of Life (EORTC QLQ-LC43) | Up to 5 years | Quality of life is assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 43 (QLQ-LC43). Mean change from baseline in global health status and symptom scales will be evaluated at multiple time points. |
| Healthcare Economic Outcomes | Up to 5 years | Total medical costs (including direct costs of treatment, hospitalization, and follow-up) and hospital readmission rates will be compared between the MDT group and historical control group. |
| Disease Control Rate (DCR) | Up to 5 years | DCR is defined as the proportion of patients with CR, PR, or stable disease (SD) according to RECIST v1.1 criteria. |
Countries
China
Contacts
CONTACTYu Tong, Master's degree
Outcome results
None listed