Clinical trial · Interventional
MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients
Establishment and Validation of a Multidisciplinary Team (MDT)-Based Umbrella Decision-making and Treatment Model for Geriatric Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDT-Based Umbrella Decision-Making Model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDT Group
- description
- Participants receive individualized treatment plans formulated by a multidisciplinary team (MDT) based on comprehensive geriatric assessment and tumor characteristics. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. All patients undergo standardized follow-up according to protocol.
- interventionNames
- Other: MDT-Based Umbrella Decision-Making Model
Primary outcomes (1)
- measure
- 3-Year Progression-Free Survival (PFS)
- timeFrame
- Up to 3 years
- description
- 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available