ELDAPT: Elderly with locally advanced Lung cancer: Deciding through geriatric Assessment on the oPtimal Treatment strategy

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.

Developing a clinically applicable geriatric screening instrument to stratify
medically fit patients who may benefit from intensified treatment strategies
and frail patients who will undergo best supportive care (which may include
palliative RT), (2) collecting evidence on the treatment with the highest QAS
and (3) evaluation and clinical implementation of the project results,
including a flow chart for safe and cost-effective clinical decision-making, in
clinical practice.

• To perform geriatric assessment in stage III NSCLC patients to select
patients fit enough to undergo intensified treatment
• To identify reliable elements of the geriatric assessment that are predictive
for treatment tolerance and QAS in elderly patients with stage III NSCLC
• To determine the predictive value of saliva biomarkers to treatment tolerance
and QAS in elderly patients with stage III NSCLCTo develop and validate a
clinically applicable geriatric screening instrument that enables appropriate
treatment stratification in the elderly NSCLC patient
• To compare different treatment strategies in fit elderly patients with
respect to
o Overall survival
o Quality adjusted survival
• To compare cost-effectiveness of different treatment strategies for fit
elderly patients with stage III NSCLC

A multicentre, non-randomized intervention study. All registered patients will
undergo a geriatric assessment to determine the vulnerability. After this the
registered patients will be followed (short questionnaires) to compare
different treatment strategies (competitor CHRT, sequential CHRT and Radical
RT) in elderly patients.

All registered patients will have an initial geriatric assessment to assess
vulnerability.

The burden associated with participation in this study consists of undergoing
an extensive geriatric screening (time burden ± 1,5 hours) and the filling in
of questionnaires (time burden ± 10 minutes, 1 month after treatment, 3 monthly
the first year after treatment, 6 monthly the 2nd year, and yearly thereafter
until 5 years after treatment). Optional saliva samples for biomarker analysis
will be taken twice, at standard hospital visits. Site visits and physical
examinations will be performed according to standard treatment.