NCT02284308

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2016Dec 2029

First Submitted

Initial submission to the registry

October 30, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2029

Expected
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

8.5 years

First QC Date

October 30, 2014

Last Update Submit

July 2, 2025

Conditions

NSCLC

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Geriatric assessment

    Baseline

  • Medical comparison between treatments

    5 years

  • Cost-effectiveness

    End of study

  • Development and validation of geriatric screening instrument

    5 years

  • Flow chart

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Patients with any subtype of NSCLC, primary UICC Stage III, age ≥ 75 years

All registered patients will undergo a geriatric assessment to assess vulnerability. Based on this assessment, patients are offered treatment according to the discretion of the physician and patient.

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged ≥ 75 years, with any subtype of NSCLC, stage III

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Ziekenhuisgroep Twente

Almelo, 7609 PP, Netherlands

Location

Gelre ziekenhuis

Apeldoorn, 7334 DZ, Netherlands

Location

Radiotherapiegroep Arnhem

Arnhem, 6815 AD, Netherlands

Location

Rijnstate

Arnhem, 6815 AD, Netherlands

Location

Deventer Hospital

Deventer, 7416 SE, Netherlands

Location

Gelderse Vallei

Ede, 6716 RP, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Máxima MC

Eindhoven, 5631 BM, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Rivas Zorggroep

Gorinchem, 4200 AB, Netherlands

Location

Groen Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

Location

Zuyderland

Heerlen, 6419 PC, Netherlands

Location

Maastro

Maastricht, 6229 ET, Netherlands

Location

MUMC+

Maastricht, 6229 HX, Netherlands

Location

Canisius-Wilhelmina Hospital

Nijmegen, 6532 SZ, Netherlands

Location

Laurentius Hospital

Roermond, 6043 VC, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Haga Ziekenhuis

The Hague, 2504 LN, Netherlands

Location

Haaglanden MC

The Hague, 2512 VA, Netherlands

Location

VieCuri MC

Venlo, 5912 BL, Netherlands

Location

Zaans MC

Zaandam, 1502 DV, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29651598DERIVED

Study Officials

  • Judith van Loon, MD, PhD

    Maastro (radiotherapist)

    PRINCIPAL INVESTIGATOR

  • Anne-Marie Dingemans, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Mariska Janssen-Heijnen, PhD

    VieCuri Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 6, 2014

Study Start

July 1, 2016

Primary Completion

January 1, 2025

Study Completion (Estimated)

December 18, 2029

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(22)