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

N/AActive Not RecruitingNCT02284308

Maastricht Radiation Oncology180 enrolled

Overview

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.

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

180

Conditions

NSCLC

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (22)

Ziekenhuisgroep Twente

Almelo, Netherlands

Gelre ziekenhuis

Apeldoorn, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

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

Time frame: Baseline

Medical comparison between treatments

To compare different treatment strategies for fit elderly patients with respect to overall and quality adjusted survival

Time frame: 5 years

Cost-effectiveness

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

Time frame: End of study

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

Time frame: 5 years

Flow chart

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

Time frame: 5 years

Predictive value

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

Data from ClinicalTrials.gov

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