NCT07509333

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
113mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Dec 2035

First Submitted

Initial submission to the registry

March 5, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 5, 2026

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2033

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

7 years

First QC Date

March 5, 2026

Last Update Submit

August 30, 2026

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Keywords

Lung cancerElderlyGeriatricMultidisciplinary teamUmbrella trial

Outcome Measures

Primary Outcomes (1)

  • 3-Year Progression-Free Survival (PFS)

    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.

    Up to 3 years

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

MDT Group

EXPERIMENTAL

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.

Other: MDT-Based Umbrella Decision-Making Model

Interventions

MDT-Based Umbrella Decision-Making ModelOTHER

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, results of clinically indicated tumor somatic molecular testing when available, and functional status. Based on this evaluation, the team formulates and oversees the implementation of individualized treatment plans across multiple therapeutic modalities (surgery, ablation, SBRT, targeted therapy, immunotherapy, etc.) and standardized follow-up protocols, tailored to distinct patient subgroups within the umbrella trial framework.

MDT Group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Lung cancer cannot be confirmed by histologic or cytologic examination.
  • A medical emergency requiring immediate treatment that precludes completion of the baseline study procedures and MDT review before treatment initiation.
  • Cognitive or communication impairment that prevents completion of the core study procedures when no legally authorized representative or appropriate proxy assistance is available.
  • A contraindication to all clinically acceptable methods required for the core study-specific baseline assessment, with no suitable alternative assessment available.
  • Concurrent participation in another interventional study that mandates a treatment strategy incompatible with the CGA-informed MDT care pathway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

Yu Tong, Master's degree

CONTACT

18180182544tongyu0218@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

March 5, 2026

First Posted

April 3, 2026

Study Start

April 5, 2026

Primary Completion (Estimated)

April 5, 2033

Study Completion (Estimated)

December 31, 2035

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because the dataset contains sensitive clinical, imaging, and potentially genomic information and is subject to institutional and applicable national data-protection requirements. The study protocol, statistical analysis plan, and de-identified aggregate results may be made available upon reasonable request and approval by the responsible institution.

Locations

CN(1)