Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
NCT05463224
NSCLC
Seoul, Gangnamgu, South Korea
View Trial DetailsNCT Number: NCT02284308
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.
This study is active but is not currently recruiting participants.
75 year and older
All sexes
Observational
Ziekenhuisgroep Twente, Almelo, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(according to the protocol):
Time frame: 5 years
To corellate results of the geriatric assessment with quality-adjusted survival (QAS) after radical intent therapy in patients with stage III NSCLC ≥75 years
Time frame: Baseline
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
Time frame: 5 years
To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival
Time frame: End of study
To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC
Time frame: 5 years
To develop and validate a clinically applicable geriatric screening instrument that enables appropriate treatment stratification in the elderly NSCLC patient
Time frame: 5 years
To develop a flow chart for cost-effective clinical decision-making, in clinical practice
Time frame: 5 years
To determine the predictive value of saliva biomarkers on QAS in elderly patients with stage III NSCLC
Maastricht Radiation Oncology
Other
ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy
Acronym: ELDAPT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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