Non-small Cell Lung CancerLIVELUNGNCT05919641
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
An observational study of Non-small Cell Lung Cancer and Stereotactic Body Radiotherapy, run by Odense University Hospital at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Stereotactic Body Radiotherapy, Comprehensive Geriatric Assessment
- What is being tested?
- Comprehensive Geriatric Assessment
- How many people
- 130 participants
- Where
- 4 sitesDenmark
- Study dates
- 29 Sep 2020to 1 Apr 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Missing histology/cytology
- Another current malignancy
- Higher staging at treatment planning
- Not able to provide informed consent
- Do not speak or understand Danish
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 4 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Hjørdis H Schmidt, M.D., hjoerdis.schmidt@auh.rm.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Mette Poehl, M.D, Phd, mette.poehl@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Kristian K Bentsen, M.D., 004528735210, kristian.kirkelund.bentsen3@rsyd.dk
- Recruiting
Vejle Hospital
Vejle, 7100
Charlotte Kristiansen, M.D., PhD, Charlotte.Kristiansen@rsyd.dk
About this study
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
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
- Being tested
- Comprehensive Geriatric Assessment
- Keywords
- NSCLC, SBRT, CGA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| +CGA | Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA) Receives: Other: Comprehensive Geriatric Assessment | |
| -CGA | Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Overall Survival (OS)
The time from treatment to death, regardless of disease recurrence
Measured: 12 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 9 months
Hand-grip strength
Hand-grip strength measured in kilo using a JAMAR hand dynamometer
Measured: 12 months
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
Measured: 12 months
Chair-stand-test (CST)
The CST involves recording the number of "stands" from a chair a person can complete in 30 seconds
Measured: 12 months
Unplanned Admissions
Time to first unplanned admission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start29 Sep 2020
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Kirkelund Bentsen, Odense University Hospital
- Investigators
- Kristian K Bentsen, Dr. med, Principal investigator, Department of Oncology, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919641
- Sponsor's protocol ID
- LIVELUNG
- Acronym
- LIVELUNG
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05919641
- Acronym / sponsor ID
- LIVELUNG / LIVELUNG
- Conditions
- Non-small Cell Lung Cancer, Stereotactic Body Radiotherapy, Comprehensive Geriatric Assessment
- Keywords
- NSCLC, SBRT, CGA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| +CGA | – | Other: Comprehensive Geriatric AssessmentPatients randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
| -CGA | – | –Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Missing histology/cytology
- Another current malignancy
- Higher staging at treatment planning
- Not able to provide informed consent
- Do not speak or understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentComprehensive 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. | Other | +CGA |
Primary outcome
Quality of Life (EQ-5D)
Time frame: 12 months
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.
8 secondary outcomes
Overall Survival (OS)
Time frame: 12 months
Quality of Life (EQ-5D)
Time frame: 3 months
Quality of Life (EQ-5D)
Time frame: 6 months
Quality of Life (EQ-5D)
Time frame: 9 months
Hand-grip strength
Time frame: 12 months
Timed-up-and-go (TUG)
Time frame: 12 months
Chair-stand-test (CST)
Time frame: 12 months
Unplanned Admissions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian K Bentsen, Dr. med principal investigator
Department of Oncology, Odense University Hospital, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Stereotactic Body Radiotherapy, run by Odense University Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian K Bentsen, Dr.med. (004528735210, kristian.kirkelund.bentsen3@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EQ-5D) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.