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

July 2, 2025 updated by: Maastricht Radiation Oncology

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Ziekenhuisgroep Twente
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuis
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate
      • Arnhem, Netherlands, 6815 AD
        • Radiotherapiegroep Arnhem
      • Den Haag, Netherlands, 2504 LN
        • Haga Ziekenhuis
      • Den Haag, Netherlands, 2512 VA
        • Haaglanden MC
      • Deventer, Netherlands, 7416 SE
        • Deventer Hospital
      • Ede, Netherlands, 6716 RP
        • Gelderse Vallei
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
      • Eindhoven, Netherlands, 5631 BM
        • Máxima MC
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Gorinchem, Netherlands, 4200 AB
        • Rivas Zorggroep
      • Gouda, Netherlands, 2803 HH
        • Groen Hart Ziekenhuis
      • Heerlen, Netherlands, 6419 PC
        • Zuyderland
      • Maastricht, Netherlands, 6229 ET
        • Maastro
      • Maastricht, Netherlands, 6229 HX
        • MUMC+
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Hospital
      • Roermond, Netherlands, 6043 VC
        • Laurentius Hospital
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis
      • Venlo, Netherlands, 5912 BL
        • Viecuri MC
      • Zaandam, Netherlands, 1502 DV
        • Zaans MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥ 75 years, with any subtype of NSCLC, stage III

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation GA with QAS (quality adjusted survival)
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
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Collaborators

AstraZeneca
Dutch Society of Physicians for Pulmonology and Tuberculosis
Erasmus Medical Center
VieCuri Medical Centre
Dutch Cancer Society

Investigators

  • Principal Investigator: Judith van Loon, MD, PhD, Maastro (radiotherapist)
  • Principal Investigator: Mariska Janssen-Heijnen, PhD, Viecuri Medical Centre
  • Principal Investigator: Anne-Marie Dingemans, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

December 18, 2029

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimated)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

July 4, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ELDAPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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