MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients
Recruiting · NCT07509333 · Interventional (participants receive a specific treatment) · Lead sponsor: West China Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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:
- Known contraindication to iodine-based contrast agents or MRI (e.g., incompatible metallic implants).
- Known 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.
Where it is running
1 location listed.
- West China Hospital, Sichuan University - Chengdu, Sichuan, China