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

NSCLC Clinical Trial

— ELDAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02284308
• Other study ID #: ELDAPT
• Status: Recruiting
• Start date: July 2016
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: Maastricht Radiation Oncology
• Contact: Judith van Loon, MD, PhD
• Phone: +31 88 44 55 600
• Email: judith.vanloon[@]maastro.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• NSCLC

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Gelre ziekenhuis	Apeldoorn
Netherlands	Radiotherapiegroep Arnhem	Arnhem
Netherlands	Rijnstate	Arnhem
Netherlands	Haaglanden MC	Den Haag
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Deventer Hospital	Deventer
Netherlands	Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Máxima MC	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Groen Hart Ziekenhuis	Gouda
Netherlands	Zuyderland	Heerlen
Netherlands	Maastro	Maastricht
Netherlands	MUMC+	Maastricht
Netherlands	Canisius-Wilhelmina Hospital	Nijmegen
Netherlands	Laurentius Hospital	Roermond
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	VieCuri MC	Venlo
Netherlands	Zaans MC	Zaandam

Sponsors (6)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	AstraZeneca, Dutch Cancer Society, Dutch Society of Physicians for Pulmonology and Tuberculosis, Erasmus Medical Center, VieCuri Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

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