Impact of comprehensive geriatric assessment in older patients with localized lung cancer treated with radiation therapy
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
Odense University Hospital · NCT05919641
This study is testing if a thorough health check for older patients with localized lung cancer receiving radiation therapy can help them feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 4 sites (Aarhus, Aarhus N and 3 other locations) |
| Trial ID | NCT05919641 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of a comprehensive geriatric assessment (CGA) on older patients diagnosed with localized non-small cell lung cancer (NSCLC) who are treated with stereotactic body radiation therapy (SBRT). The study will include 130 patients across five cancer centers in Denmark and will assess outcomes such as quality of life, overall survival, physical functionality, and unplanned hospital admissions. By integrating CGA into the treatment plan, the study seeks to determine if it can improve the general health status of these patients and potentially influence standard clinical practices.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older with localized NSCLC who are considered medically inoperable or too frail for surgery.
Not a fit: Patients with higher staging of cancer, other current malignancies, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and survival outcomes for older patients with localized NSCLC undergoing radiation therapy.
How similar studies have performed: While the approach of integrating CGA in cancer treatment is gaining attention, this specific study's methodology is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus, Aarhus N and 3 other locations
- Aarhus University Hospital — Aarhus, Aarhus N, Denmark (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Odense University Hospital — Odense, Denmark (RECRUITING)
- Vejle Hospital — Vejle, Denmark (RECRUITING)
Study contacts
- Principal investigator: Kristian K Bentsen, Dr. med — Department of Oncology, Odense University Hospital, Denmark
- Study coordinator: Kristian K Bentsen, Dr.med.
- Email: kristian.kirkelund.bentsen3@rsyd.dk
- Phone: 004528735210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Stereotactic Body Radiotherapy, Comprehensive Geriatric Assessment, NSCLC, SBRT, CGA