Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the Optimal Treatment Strategy

Study Overview
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Brief Summary
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There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients.

Detailed Description
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Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

Official Title
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ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy

Conditions
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NSCLC

Participation Criteria
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Eligibility Criteria
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Any subtype of pathologically proven NSCLC, primary UICC Stage III disease; Age ≥ 75 years; No surgery or adjuvant chemotherapy for NSCLC in the last year; No prior radiotherapy to the ipsilateral thorax or mediastinum; No clinical superior vena cava syndrome; No diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer); Written informed consent

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years<br>All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation GA with QAS (quality adjusted survival) | To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric assessment | To perform a geriatric assessment in stage III NSCLC patients to distinguish patients fit enough to undergo intensified treatment and to develop a reliable and clinically applicable geriatric screening instrument to guide treatment decisions in stage III NSCLC | Baseline | 
| Medical comparison between treatments | To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival | 5 years | 
| Cost-effectiveness | To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC | End of study | 
| Development and validation of geriatric screening instrument | To develop and validate a clinically applicable geriatric screening instrument that enables appropriate treatment stratification in the elderly NSCLC patient | 5 years | 
| Flow chart | To develop a flow chart for cost-effective clinical decision-making, in clinical practice | 5 years | 
| Predictive value | To determine the predictive value of saliva biomarkers on QAS in elderly patients with stage III NSCLC | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC