NCT07509333 MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients
| NCT ID | NCT07509333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | West China Hospital |
| Condition | Lung Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2025-12-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 other primary malignancies within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix). 2. Unclear pathological diagnosis (no definite histologic or cytologic evidence) or post-enrollment pathological review excludes lung cancer. 3. 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. 4. Contraindications to study-related examinations or treatments: 4.1Known contraindication to iodine-based contrast agents or MRI (e.g., incompatible metallic implants). 4.2Known severe allergy to any of the essential therapeutic agents (e.g., chemotherapy, targeted drugs) involved in the study. 5. 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. 6. 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%. 7. Concurrent participation in another interventional clinical trial for lung cancer (observational studies are allowed). 8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07509333 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 70 Years, studying Lung Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07509333 currently recruiting?
Yes, NCT07509333 is actively recruiting participants. Contact the research team at tongyu0218@163.com for enrollment information.
Where is the NCT07509333 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07509333 clinical trial?
NCT07509333 is sponsored by West China Hospital. The trial plans to enroll 2,000 participants.