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Trial Title:
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
NCT ID:
NCT05919641
Condition:
Non-small Cell Lung Cancer
Stereotactic Body Radiotherapy
Comprehensive Geriatric Assessment
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
SBRT
CGA
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Comprehensive Geriatric Assessment
Description:
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.
Arm group label:
+CGA
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Hjørdis H Schmidt, M.D.
Email:
hjoerdis.schmidt@auh.rm.dk
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Mette Poehl, M.D, Phd
Email:
mette.poehl@regionh.dk
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Kristian K Bentsen, M.D.
Phone:
004528735210
Email:
kristian.kirkelund.bentsen3@rsyd.dk
Facility:
Name:
Vejle Hospital
Address:
City:
Vejle
Zip:
7100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Charlotte Kristiansen, M.D., PhD
Email:
Charlotte.Kristiansen@rsyd.dk
Start date:
September 29, 2020
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919641
