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Active, Not Recruiting

NCT Number: NCT02284308

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuisgroep Twente, Almelo, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Cost-effectiveness

    Time frame: End of study

    To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC

  4. 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. Flow chart

    Time frame: 5 years

    To develop a flow chart for cost-effective clinical decision-making, in clinical practice

  6. Predictive value

    Time frame: 5 years

    To determine the predictive value of saliva biomarkers on QAS in elderly patients with stage III NSCLC

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ELDAPT

Important dates

Study start
2016
Primary completion
2025
Study completion
2029
First posted
Nov 6, 2014
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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