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

June 22, 2023 updated by: Kristian Kirkelund Bentsen, Odense University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
+CGA
Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA)
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.
-CGA
Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 12 months
The time from treatment to death, regardless of disease recurrence
12 months
Quality of Life (EQ-5D)
Time Frame: 3 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.
3 months
Quality of Life (EQ-5D)
Time Frame: 6 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.
6 months
Quality of Life (EQ-5D)
Time Frame: 9 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.
9 months
Hand-grip strength
Time Frame: 12 months
Hand-grip strength measured in kilo using a JAMAR hand dynamometer
12 months
Timed-up-and-go (TUG)
Time Frame: 12 months
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
Chair-stand-test (CST)
Time Frame: 12 months
The CST involves recording the number of "stands" from a chair a person can complete in 30 seconds
12 months
Unplanned Admissions
Time Frame: 12 months
Time to first unplanned admission
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Kristian K Bentsen, Dr. med, Department of Oncology, Odense University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVELUNG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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