LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT

NCT05919641 | Unknown DMC

• 1 other identifier: LIVELUNG
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 4

Brief Summary

Older patients with non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often die from other causes than lung cancer due to age-related comorbidities. This national randomized study will include 130 patients throughout 5 Danish cancer centres and investigate if a comprehensive geriatric intervention (CGA) when added upfront to SBRT for patients with localized NSCLC will have an impact on quality of life (QoL), overall survival, physical functionality and unplanned hospital admissions. If an upfront CGA improves patients' general health status, this study could lead to implementation of a CGA in standard clinical practice as well as further research on older patients receiving radiotherapy.

Conditions

Non-small Cell Lung Cancer; Stereotactic Body Radiotherapy; Comprehensive Geriatric Assessment

Keywords

NSCLC; SBRT; CGA

Outcome Measures

Primary Outcomes (1)

• Quality of Life (EQ-5D)

  Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status.

  12 months

Secondary Outcomes (8)

• Overall Survival (OS)

  12 months

• Quality of Life (EQ-5D)

  3 months

• Quality of Life (EQ-5D)

  6 months

• Quality of Life (EQ-5D)

  9 months

• Hand-grip strength

  12 months

Study Arms (2)

+CGA

Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA)

Other: Comprehensive Geriatric Assessment

-CGA

Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA)

Interventions

Comprehensive Geriatric Assessment OTHER

Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging.

+CGA

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients, able to provide informed consent, aged ≥70 diagnosed with T1-3N0M0 NSCLC considered medically inoperable at a multidisciplinary setting and therefore candidates for SBRT. 130 patients will be included in a period of 24 months.

You may qualify if:

• Patients with cytologically or histologically proven non-small cell lung cancer
• Stage T1-3N0M0
• ≥ 70 years old
• In a multidisciplinary setting the patient is considered medically inoperable, too frail for operation due to age and/or comorbidity or that the patient refuse surgery and therefore candidate for SBRT.

You may not qualify if:

• Missing histology/cytology
• Another current malignancy
• Higher staging at treatment planning
• Not able to provide informed consent
• Do not speak or understand Danish

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (4)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Kristian K Bentsen, Dr. med

  Department of Oncology, Odense University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian K Bentsen, Dr.med.

CONTACT

004528735210; kristian.kirkelund.bentsen3@rsyd.dk

Stefan S Jeppesen, Dr.med

CONTACT

004530502948; Stefan.Jeppesen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 26, 2023
• Study Start: September 29, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)