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MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients
MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients

NCT07509333

RecruitingNA

Sponsor: West China Hospital

Conditions: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

Interventions: MDT-Based Umbrella Decision-Making Model

Countries: China

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 overview

Sex: ALL

Age: 60 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Chengdu, Sichuan, China