Clinical trial NCT02284308: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the Optimal Treatment Strategy
Official title: ELDAPT: Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the oPtimal Treatment Strategy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: NSCLC
Keywords: NSCLC
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Dutch Society of Physicians for Pulmonology and Tuberculosis
name: Erasmus Medical Center
name: VieCuri Medical Centre
name: AstraZeneca
name: Dutch Cancer Society
First posted: 2014-11-06
Enrollment: 180
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥ 75 years, with any subtype of NSCLC, stage III

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Correlation GA with QAS (quality adjusted survival)
timeFrame: 5 years
Secondary outcomes:
measure: Geriatric assessment
timeFrame: Baseline
measure: Medical comparison between treatments
timeFrame: 5 years
measure: Cost-effectiveness
timeFrame: End of study
measure: Development and validation of geriatric screening instrument
timeFrame: 5 years
measure: Flow chart
timeFrame: 5 years
measure: Predictive value
timeFrame: 5 years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuis
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep Arnhem
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden MC
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Ede
country: Netherlands
facility: Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Máxima MC
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Gorinchem
country: Netherlands
facility: Rivas Zorggroep
city: Gouda
country: Netherlands
facility: Groen Hart Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland
city: Maastricht
country: Netherlands
facility: Maastro
city: Maastricht
country: Netherlands
facility: MUMC+
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
city: Roermond
country: Netherlands
facility: Laurentius Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri MC
city: Zaandam
country: Netherlands
facility: Zaans MC
Study officials:
affiliation: Maastro (radiotherapist)
name: Judith van Loon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Anne-Marie Dingemans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VieCuri Medical Centre
name: Mariska Janssen-Heijnen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Driessen EJM, van Loon JGM, Maas HA, Dingemans AC, Janssen-Heijnen MLG. Geriatric Assessment for Older Patients with Non-small Cell Lung Cancer: Daily Practice of Centers Participating in the NVALT25-ELDAPT Trial. Lung. 2018 Aug;196(4):463-468. doi: 10.1007/s00408-018-0116-8. Epub 2018 Apr 12.