Clinical trial NCT05919641: LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Stereotactic Body Radiotherapy
Comprehensive Geriatric Assessment
Keywords: NSCLC
SBRT
CGA
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 130
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life (EQ-5D)
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Quality of Life (EQ-5D)
timeFrame: 3 months
measure: Quality of Life (EQ-5D)
timeFrame: 6 months
measure: Quality of Life (EQ-5D)
timeFrame: 9 months
measure: Hand-grip strength
timeFrame: 12 months
measure: Timed-up-and-go (TUG)
timeFrame: 12 months
measure: Chair-stand-test (CST)
timeFrame: 12 months
measure: Unplanned Admissions
timeFrame: 12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Department of Oncology, Odense University Hospital, Denmark
name: Kristian K Bentsen, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: