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

Active, not recruiting

• Conditions: NSCLC

• Registration Number: NCT02284308
• Lead Sponsor: Maastricht Radiation Oncology

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.

Study Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Study Start: 2016-07
• Status Verified: 2025-01
• Primary Completion: 2025-01-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Study Completion: 2029-12-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Flow chart	5 years	To develop a flow chart for cost-effective clinical decision-making, in clinical practice
Medical comparison between treatments	5 years	To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival
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
Cost-effectiveness	End of study	To compare cost-effectiveness of sequential and concurrent RCHT for fit elderly patients with stage III NSCLC
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

Trial Locations

Locations (22)

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

Gelre ziekenhuis; 🇳🇱 Apeldoorn, Netherlands

Radiotherapiegroep Arnhem; 🇳🇱 Arnhem, Netherlands

Máxima MC; 🇳🇱 Eindhoven, Netherlands

Canisius-Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands

Haga Ziekenhuis; 🇳🇱 Den Haag, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Haaglanden MC; 🇳🇱 Den Haag, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Groen Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Deventer Hospital; 🇳🇱 Deventer, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Rivas Zorggroep; 🇳🇱 Gorinchem, Netherlands

MUMC+; 🇳🇱 Maastricht, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Gelderse Vallei; 🇳🇱 Ede, Netherlands

Zuyderland; 🇳🇱 Heerlen, Netherlands

Maastro; 🇳🇱 Maastricht, Netherlands

Laurentius Hospital; 🇳🇱 Roermond, Netherlands

VieCuri MC; 🇳🇱 Venlo, Netherlands

Zaans MC; 🇳🇱 Zaandam, Netherlands