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

Non-small Cell Lung Cancer Clinical Trial

— LIVELUNG  

Official title:

LIVELUNG - Impact of CGA on QoL, Overall Survival and the Need for Admission in Patients Diagnosed With Localized NSCLC Treated With SBRT - a National Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919641
• Other study ID #: LIVELUNG
• Status: Recruiting
• Start date: September 29, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2023
• Source: Odense University Hospital
• Contact: Kristian K Bentsen, Dr.med.
• Phone: 004528735210
• Email: kristian.kirkelund.bentsen3[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Comprehensive Geriatric Assessment
• Non-small Cell Lung Cancer
• Stereotactic Body Radiotherapy

Intervention

Other:
• Comprehensive Geriatric Assessment
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	The time from treatment to death, regardless of disease recurrence	12 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	Hand-grip strength	Hand-grip strength measured in kilo using a JAMAR hand dynamometer	12 months
Secondary	Timed-up-and-go (TUG)	TUG consists of timing (seconds) a patient getting up from a chair from the sitting to the bipedal position, walking three meters, turning, returning, and sitting on the chair again	12 months
Secondary	Chair-stand-test (CST)	The CST involves recording the number of "stands" from a chair a person can complete in 30 seconds	12 months
Secondary	Unplanned Admissions	Time to first unplanned admission	12 months