The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients

Last updated: February 4, 2025
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

18F FDG PET/CT

CT scan

Clinical Study ID

NCT06082492
114319
NL83288.091.23
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computerized Tomography (18F FDG PET/CT) versus follow-up with conventional CT surveillance.

Participants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET/CT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group.

Other tasks include:

  • filling in quality of life (QOL) questionnaires at every time point;

  • participating in an interview evaluating the addition of the 18F FDG PET/CT scans (optional);

  • collecting blood at the follow-up time points for our secondary endpoint (optional).

Researchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET/CT scans are (cost-)effective.

Eligibility Criteria

Inclusion

Eligible for this study are patients with stage III NSCLC (8th edition TNM Classification) who (are about to) start(ed) follow-up care (which may include adjuvant treatment) at a participating hospital. Patients may already be included during their curative intent treatment. Patients enter a screening period that runs until their randomization.

Inclusion Criteria:

To be eligible to participate in this study, a subject must meet all of the following criteria at the timing of randomization:

  • Cytological or histologically proven stage III non-small cell lung cancer beforestart of curative intent treatment

  • Treated with curative intent and started follow-up care

  • All adjuvant treatments are permitted as co-intervention during follow-up care

  • Age 18 years or older

  • ECOG Performance Status classification 0-2 at moment of inclusion

  • Written and signed informed consent by the patient or patient's representative (withthe understanding that consent may be withdrawn by the patient or patient'srepresentative at any time without consequences to future medical care)

Exclusion

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Life expectancy shorter than 6 months at the end of curative intent treatment

  • Evidence of recurrence after end of curative intent treatment and beforerandomization (4 months follow-up)

  • Any condition that, in the opinion of the investigator, would interfere withevaluation of the intervention or interpretation of HRQOL or other study results.

Study Design

Total Participants: 690
Treatment Group(s): 2
Primary Treatment: 18F FDG PET/CT
Phase:
Study Start date:
March 19, 2024
Estimated Completion Date:
June 30, 2029

Study Description

Stage III non-small cell lung cancer (NSCLC) patients are at high risk of developing recurrences (50-78%) during follow-up. With more effective treatments available for patients with oligometastatic disease, early detection of tumor recurrence can prolong survival and health-related quality of life and thereby lower the disease burden. With the use of 18F FDG PET/CT during follow-up, recurrences may be detected earlier at an oligometastatic state when curative-intent treatment is still possible.

Primary objective:

  • The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance.

The secondary objectives of this study are:

  • To compare the 2-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance (interim analysis);

  • To compare the number of detected (symptomatic and asymptomatic) recurrences of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;

  • To compare the event-free survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;

  • To determine the cost-effectiveness of 18F FDG PET/CT versus conventional CT-based surveillance during follow-up of stage III NSCLC patients;

  • To compare the effect of 18F FDG PET/CT versus conventional CT-based surveillance on health-related quality of life during follow-up of stage III NSCLC patients;

  • To assess the beneficial value of ctDNA in the detection of recurrences during follow-up in stage III NSCLC patients;

  • To identify patients' experiences with the additional 18F FDG PET/CT scans in the follow-up of stage III NSCLC patients.

  • To assess differences in type of treatment following recurrence during follow-up in stage III NSCLC patients.

Primary analyses will be performed on an intention-to-treat basis as well as per protocol. Kaplan-Meier curves with stratified log-rank 2-sided tests will be used to compare the survival between groups. In case of empty strata, strata will be collapsed. The clinical relevance of the difference will be primarily expressed in terms of 3-year survival of the intervention versus the control group.

Connect with a study center

  • Tergooi MC

    Hilversum, Utrecht 1212 VG
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek/Nederlands Kanker Instituut

    Amsterdam,
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Gelre Ziekenhuizen

    Apeldoorn & Zutphen,
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Active - Recruiting

  • Haaglanden Medisch Centrum

    Den Haag,
    Netherlands

    Active - Recruiting

  • HagaZiekenhuis

    Den Haag,
    Netherlands

    Active - Recruiting

  • Deventer Ziekenhuis

    Deventer,
    Netherlands

    Active - Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede,
    Netherlands

    Active - Recruiting

  • Máxima Medisch Centrum

    Eindhoven & Veldhoven,
    Netherlands

    Active - Recruiting

  • Treant

    Emmen,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • Groene Hart Ziekenhuis

    Gouda,
    Netherlands

    Active - Recruiting

  • Martini Ziekenhuis

    Groningen,
    Netherlands

    Active - Recruiting

  • Tjongerschans ziekenhuis

    Heerenveen,
    Netherlands

    Active - Recruiting

  • Dijklander Ziekenhuis

    Hoorn,
    Netherlands

    Active - Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Radboudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Bravis Ziekenhuis

    Roosendaal,
    Netherlands

    Active - Recruiting

  • Maasstad ZIekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis & Vlietland

    Schiedam,
    Netherlands

    Active - Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg,
    Netherlands

    Active - Recruiting

  • Diakonessenhuis

    Utrecht,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Utrecht & Nieuwegein,
    Netherlands

    Active - Recruiting

  • Streekziekenhuis Koningin Beatrix

    Winterswijk,
    Netherlands

    Active - Recruiting

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