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AzTrials

Stage III Non-small Cell Lung CancerNVALT31-PETNCT06082492

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

A study testing 18F FDG PET/CT and CT scan in people with Stage III Non-small Cell Lung Cancer, run by Radboud University Medical Center at 27 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage III Non-small Cell Lung Cancer
What is being tested?
18F FDG PET/CT and CT scan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
690 participants
Where
27 sitesNetherlands
Study dates
19 Mar 2024to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)

Who cannot join

  • 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 before randomization (4 months follow-up)
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

NVALT31-PET study team contact

+31611469084

NVALT31PET@radboudumc.nl

Nicole E. Billingy, MSc. contact

+31611469084

nicole.billingy@radboudumc.nl

27 sites in 1 country

Netherlands27 sites, 27 recruiting

  • Amsterdam UMC

    Amsterdam

    M. Smink

    A. Becker-Commissaris, Dr.

    Recruiting

  • Antoni van Leeuwenhoek/Nederlands Kanker Instituut

    Amsterdam

    E. Schouten

    J. van Diessen, Dr.

    Recruiting

  • OLVG

    Amsterdam

    Research Longgeneeskunde, research-longgeneeskunde@olvg.nl

    A. Moons-Pasic, Dr.

    Recruiting

  • Gelre Ziekenhuizen

    Apeldoorn & Zutphen

    M. van Nistelrooij

    E. Lammers, Dr.

    Recruiting

  • Amphia Ziekenhuis

    Breda

    Research Longoncologie

    N. van Walree, Dr.

    Recruiting

  • Deventer Ziekenhuis

    Deventer

    Research Oncologie

    R. Boshuizen, Dr.

    Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede

    A. Mulders, amulders@zgv.nl

    A. Mulders, Dr.

    Recruiting

  • Máxima Medisch Centrum

    Eindhoven & Veldhoven

    M. Bax

    M. Youssef, Dr.

    Recruiting

  • Treant

    Emmen

    T. Bokhorst

    S. Rutgers, Dr.

    Recruiting

  • Medisch Spectrum Twente

    Enschede

    Onderzoeksbureau Longgeneeskunde, Onderzoeksbureau.longgeneeskunde@mst.nl

    E. Citgez, Dr.

    Recruiting

  • Groene Hart Ziekenhuis

    Gouda

    K. van Elst

    E. Geraedts, Dr.

    Recruiting

  • Martini Ziekenhuis

    Groningen

    I. Jonker

    J. van Putten, Dr.

    Recruiting

  • Tjongerschans ziekenhuis

    Heerenveen

    H. Langenberg-Post

    M. de Vries, Dr.

    Recruiting

  • Tergooi MC

    Hilversum, Utrecht, 1212 VG

    L. Kwast

    J. van Haarst, Dr.

    Recruiting

  • Dijklander Ziekenhuis

    Hoorn

    Y. van Dekken

    M. van Laren, Dr.

    Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

    Research Long

    Y. Berk, Dr.

    Recruiting

  • Radboudumc

    Nijmegen

    Nicole E. Billingy, MSc., +31611469084, nicole.billingy@radboudumc.nl

    NVALT31-PET Study Team, +31611469084, nvalt31pet@radboudumc.nl

    Recruiting

  • Bravis Ziekenhuis

    Roosendaal

    J. Schellekens

    K. van Loenhout, Dr.

    Recruiting

  • Maasstad ZIekenhuis

    Rotterdam

    Research Oncologie

    S. van 't Westeinde, Dr.

    Recruiting

  • Franciscus Gasthuis & Vlietland

    Schiedam

    S. Broerse

    J. Dits, Dr.

    Recruiting

  • Haaglanden Medisch Centrum

    The Hague

    E. Gortmaker

    K. Maas, Dr.

    Recruiting

  • HagaZiekenhuis

    The Hague

    Research Longziekten

    P. Brocken, Dr.

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg

    A. Velthoven

    M. Schiefer, Dr.

    Recruiting

  • Diakonessenhuis

    Utrecht

    Research Oncologie

    K. Dr. K. Schulkes, Dr.

    Recruiting

  • UMC Utrecht

    Utrecht

    S. Jans, s.r.jans-2@umcutrecht.nl

    A.S.R. Lindert, Dr.

    Recruiting

  • St. Antonius Ziekenhuis

    Utrecht & Nieuwegein

    R&D Longoncologie

    L. Kastelijn, Dr.

    Recruiting

  • Streekziekenhuis Koningin Beatrix

    Winterswijk

    E. Klein Zeggelink, e.kleinzeggelink-grijsen@skbwinterswijk.nl

    M.A. Kroeze, Dr.

    Recruiting

Other trials in Netherlands

About this study

Official title: The Beneficial Value of 18F FDG PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients: the NVALT31-PET Study

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.

Read more

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.

Read the detailed 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.

Being tested
18F FDG PET/CT, CT scan
Keywords
18F FDG PET/CT scans, Follow-up care
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F FDG PET/CTDiagnostic test

    Also called Whole body PET/CT scan

    Additional 18F FDG PET/CT scans during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.

  • CT scanDiagnostic test

    CT of the thoracic region during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.

Study groups in NCT06082492
Study groupRoleWhat they receive
Intervention groupExperimentalThe intervention group (n = 345) consists of usual care until 3 years of follow-up (see comparator) with additional whole-body 18F FDG PET/CT scans (from the skull to, at least, the midfemoral region) during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up. After the 36-month follow-up period, patients will receive follow-up usual care (i.e. CT-scans). The scanning protocol of Boellaard et al (2015) is the basis of all center-specific protocols and therefore will be followed approximately (PET low dose CT 60 minutes post injection with scan trajectory from skull to (at least the) thighs followed by a CT scan).
Receives: Diagnostic Test: 18F FDG PET/CT; Diagnostic Test: CT scan
Control group (care as usual)Active comparatorThe control group (n = 345) consists of regular follow-up visits with physical check-ups and CT-scans at least every 6 months for the first 2 years and then at least yearly CT-scans until 3 years of follow-up. In case of suspected recurrence/metastasis or inconclusive results of a CT-scan (eg, after radiotherapy), 18F FDG PET/CT should be considered. The standard protocol for a diagnostic CT of the thoracic region during IV contrast administration according to the lung tumor protocol will be followed
Receives: Diagnostic Test: CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival (OS) will be defined as time from end of curative intent treatment until death or loss to follow-up or end of study defined as 3 years after end of curative treatment.

    Measured: 3 years after end of curative intent treatment

Secondary outcomes (8)

  1. Number of detected symptomatic and asymptomatic recurrences

    As seen on a scan and/or confirmed by biopsy

    Measured: Up to 3 years after end of curative intent treatment

  2. Event-free survival (EFS)

    Event-free survival will be defined as time from end of curative intent treatment until a recurrence (disease progression or relapse) or death or loss to follow-up, whichever comes first.

    Measured: 3 years after end of curative intent treatment

  3. Quality-adjusted life-years ((QALY's) for the cost-effectiveness analysis (CEA))

    The European Quality of Life Five Dimension Five Level (EQ-5D-5L) will be used to measure quality-adjusted life-years. The scores will be transformed into health utilities using the Dutch tariff. QALY's will be estimated using the area under the curve method.

    Measured: Up to 3 years after end of curative intent treatment

  4. Hospital and medical resource use (for the CEA)

    Hospital resource use will be taken from the hospital records, and will include all diagnostic testing, treatment information, hospital visits, telephone and email consultations, and medication use. Other medical resource use as measured using an adapted version of the iMTA Medical Consumption Questionnaire (iMCQ) will provide information on visits to the GP or use of paramedical care. The prices associated with resource use will be derived from the Dutch guideline for costing, and tariffs and prices published by the Dutch Health authority. Total costs will be calculated by multiplying resource use by integral cost prices.

    Measured: Up to 3 years after end of curative intent treatment

  5. Productivity losses (for the CEA)

    The iMTA Productivity Costs Questionnaire (iPCQ) will provide information on productivity losses. Productivity losses will be values by the friction cost method.

    Measured: Up to 3 years after end of curative intent treatment

  6. Health-related quality of life (HRQOL)

    As measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and lung module (EORTC-QLQ-LC13). The main HRQOL endpoints are physical functioning and the QLQ-C30 summary score. The QLQ-C30 summary score is calculated as the mean of the combined domains of the QLQ-C30 scale scores (excluding financial impact and a two-item global quality of life scale. All scale score are linearly transformed to 0-100, following EORTC guidelines. Effects on HRQOL will be investigated including all patients with at least one completed follow-up HRQOL questionnaire.

    Measured: Up to 3 years after end of curative intent treatment collected around the follow-up scans.

  7. Patients' evaluation of the 18F FDG PET/CT scans

    The impact of the additional 18F FDG PET/CT scans in follow-up care on distress will be evaluated using the 6-item Cancer Worry Scale (CWS) and the Hospital Anxiety and Depression Scale (HADS). Moreover, semi-structured interviews with a selection of patients in the intervention group will be conducted (optional).

    Measured: Up to 3 years after end of curative intent treatment collected around the follow-up scans.

  8. Blood samples

    Blood will be collected of intervention group patients in centers participating in the blood sample collection. For this, three cell-stabilizing tubes will be collected concurrently with the 18F FDG PET/CT scan, when the IV is inserted or at a planned blood test. The tubes will subsequently be sent to the sponsor within 24 hours, where the cell-stabilizing tubes will be centrifuged at room temperature for 10 min at 1600 g. Cell-free plasma will be stored in 5 mL aliquots at -80 °C until DNA isolation. Cell-free DNA will be isolated from 1 ml plasma for mutation analysis.

    Measured: Up to 3 years after end of curative intent treatment collected around the follow-up scans.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start19 Mar 2024
  3. Primary completionApr 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter randomized controlled clinical trial with a superiority design. At approximately 4 months after the end of curative intent treatment patients will be randomized 1:1 to either the intervention (18F FDG PET/CT) or the control group (usual care, CT-based follow-up). Randomization will be done stratifying for histology and treatment. After the start of the study all patients will have regular follow-up visits at 6, 12, 18, 24 months and 36 months after the end of curative intent treatment, as is stated in the Dutch guidelines. In the intervention group these visits will be complemented by a 18F FDG PET/CT scan, while in the control group the visits will only contain a CT scan. For patients in the intervention group who give consent for participation in the collection of blood, blood will be drawn around the scan. At all time points patients will be asked to fill in the HRQOL and cost-effectiveness questionnaires.
Masking
None (open label)
Enrolment
690 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082492
Sponsor's protocol ID
114319
Other IDs
NL83288.091.23
Acronym
NVALT31-PET
Status last verified
Dec 2024
First submitted
27 Sep 2023
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final (definitive) versions of data used for analysis will be made findable and shared for reuse and/or verification. Documentation/codebooks necessary for understanding the data will be made findable and shared for reuse and/or verification. Left-over blood samples will be made findable and can be accessed to share for reuse and/or verification. Metadata will be published in DANS. Metadata of the blood samples and scans will also be published in BBMRI. Crossreferences between DANS and BBMRI will be included. A DOI will be assigned to the whole dataset published in DANS Data Station Life, Health and Medical Sciences.

Publications

  • Billingy NE, Verberkt CA, Bahce I, Hassing MJ, Schoorlemmer J, Sarioglu M, Senan S, Aarntzen EHJG, Comans EFI, Kievit W, Teerenstra S, Jacobs C, Keijser A, Heuvel MMVD, Becker-Commissaris A, Walraven I; The NVALT31-PET Consortium. Beneficial value of [18F]FDG PET/CT in the follow-up of patients with stage III non-small cell lung cancer (NVALT31-PET study): study protocol of a multicentre randomised controlled trial. BMJ Open. 2025 Jul 25;15(7):e103745. doi: 10.1136/bmjopen-2025-103745.

    PubMed 40713037

Questions about this trial

What is this clinical trial studying?

A study testing 18F FDG PET/CT and CT scan in people with Stage III Non-small Cell Lung Cancer, run by Radboud University Medical Center at 27 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NVALT31-PET study team (+31611469084, NVALT31PET@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 3 years after end of curative intent treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06082492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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