Establishment and Validation of a Multidisciplinary Team (MDT)-Based Umbrella Decision-making and Treatment Model for Geriatric Lung Cancer Patients

Plain English Summary

MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients is a Not Applicable clinical trial sponsored by West China Hospital studying Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Elderly. This study tests a new way to make treatment decisions for older adults with lung cancer using a team of specialists. It is for patients aged 60-90 with newly diagnosed non-small cell or small cell lung cancer. Participation involves a comprehensive health assessment and a personalized treatment plan developed by a team of doctors. Standard treatment approaches without this specialized team model are the current alternative. The trial aims to enroll 2000 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 60 to 90 years with a confirmed diagnosis of non-small cell or small cell lung cancer. Patients must have a good general health status (ECOG 0-2) and an expected life of at least 3 months. Patients with other major cancers in the last 5 years, severe cognitive impairment, or serious organ dysfunction cannot join. Individuals with known severe allergies to study drugs or those currently in another lung cancer interventional trial are excluded. This trial is studying Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Elderly, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if patients live longer without their cancer getting worse for at least 3 years when treated using this specialized team approach. The specific primary outcome measures are: 3-Year Progression-Free Survival (PFS) (Up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to improve treatment outcomes and reduce risks for elderly lung cancer patients by using a coordinated team approach to decision-making. This research targets Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Elderly, where improved treatment options are needed.

Investor Insight

This study addresses a significant unmet need in geriatric oncology, potentially improving treatment efficacy and patient care, which could lead to a more standardized and effective approach for a gro The large enrollment target of 2000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this team-based approach is suitable for your specific lung cancer and overall health. Be prepared for comprehensive health assessments and regular follow-ups, including questionnaires about your quality of life. Treatment options will be discussed by the team, and your personalized plan will be based on your individual needs and preferences. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 2,000 participants

Interventions

• OTHER: MDT-Based Umbrella Decision-Making Model — A 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, molecular profiling, and functional status. Based on this evaluation, the team formulates and oversees the implementation of individua

Primary Outcomes

• 3-Year Progression-Free Survival (PFS) (Up to 3 years)

Secondary Outcomes

• Overall Survival (OS) (Up to 5 years)
• Disease-Free Survival (DFS) (Up to 5 years)
• Objective Response Rate (ORR) (Up to 5 years)
• Change in Quality of Life (EORTC QLQ-LC43) (Up to 5 years)
• Healthcare Economic Outcomes (Up to 5 years)

Full 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.

Trial Locations

• West China Hospital, Sichuan University, Chengdu, Sichuan, China

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Non-Small Cell Lung Carcinoma
• Small Cell Lung Carcinoma
• Geriatric Oncology
• Thoracic Oncology
• Multidisciplinary Care
• Cancer Treatment Decision-Making
• Elderly Health
• Cancer Survivorship
• Palliative Care

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