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

NCT ID: NCT05919641

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-29

Study Completion Date

2025-04-01

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer Stereotactic Body Radiotherapy Comprehensive Geriatric Assessment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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+CGA

Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA)

Comprehensive Geriatric Assessment

Intervention Type OTHER

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)

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kirkelund Bentsen

Dr.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian K Bentsen, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Odense University Hospital, Denmark

Locations

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Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Vejle Hospital

Vejle, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kristian K Bentsen, Dr.med.

Role: CONTACT

004528735210

Stefan S Jeppesen, Dr.med

Role: CONTACT

004530502948

Facility Contacts

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Hjørdis H Schmidt, M.D.

Role: primary

Mette Poehl, M.D, Phd

Role: primary

Kristian K Bentsen, M.D.

Role: primary

004528735210

Charlotte Kristiansen, M.D., PhD

Role: primary

Other Identifiers

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LIVELUNG

Identifier Type: -

Identifier Source: org_study_id

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