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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02284308

Acronym

ELDAPT

Enrollment

180

Registered

2014-11-06

Start date

2016-07-31

Completion date

2029-12-18

Last updated

2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Keywords

NSCLC

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

Inclusion criteria

(according to the protocol): * 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

Design outcomes

Primary

Measure	Time frame	Description
Correlation GA with QAS (quality adjusted survival)	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

Secondary

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

Countries

Netherlands

Outcome results