MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorWest China Hospital
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
This trial does not accept healthy volunteersQualifiers
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 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.
Lung cancer cannot be confirmed by histologic or cytologic examination.
A medical emergency requiring immediate treatment that precludes completion of the baseline study procedures and MDT review before treatment initiation.
Cognitive or communication impairment that prevents completion of the core study procedures when no legally authorized representative or appropriate proxy assistance is available.
Trial design
Design model
Single group
Treatments tested in this trial
MDT-Based Umbrella Decision-Making Model
Other interventionA 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.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: MDT GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-Year Progression-Free Survival (PFS)
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.
Time frame
Up to 3 yearsSecondary outcomes
1
Overall Survival (OS)
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.
Time frame
Up to 5 years2
Disease-Free Survival (DFS)
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.
Time frame
Up to 5 years3
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR).
Time frame
Up to 5 years4
Change in Quality of Life (EORTC QLQ-LC43)
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.
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov