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

Recruiting

• Conditions: Comprehensive Geriatric Assessment; Non-small Cell Lung Cancer; Stereotactic Body Radiotherapy
• Interventions: Other: Comprehensive Geriatric Assessment

• Registration Number: NCT05919641
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-29
• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Primary Completion: 2024-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
+CGA	Comprehensive Geriatric Assessment	Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA)

Primary Outcome Measures

Name	Time	Method
Quality of Life (EQ-5D)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark