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NCT06082492Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
690 (estimated)
First submitted
27 Sept 2023
Start date
19 Mar 2024
Primary completion date
Apr 2029
Lead sponsor
Radboud University Medical Center
Diseases
Lung cancer
NCT number
NCT06082492

What you commit to

  • Study type: Interventional
  • Planned participants: 690
  • From 19 Mar 2024 to the primary completion date, Apr 2029
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • 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)

Who the study is looking for

  • 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)

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC
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AmsterdamNetherlandsRecruiting
OLVG
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AmsterdamNetherlandsRecruiting
Antoni Van Leeuwenhoek (Nederlands Kanker Instituut)
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AmsterdamNetherlandsRecruiting
Gelre Ziekenhuizen
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Apeldoorn & ZutphenNetherlandsRecruiting
Amphia Ziekenhuis
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BredaNetherlandsRecruiting
Deventer Ziekenhuis
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DeventerNetherlandsRecruiting
Ziekenhuis Gelderse Vallei
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EdeNetherlandsRecruiting
Máxima Medisch Centrum
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Eindhoven & VeldhovenNetherlandsRecruiting
Treant
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EmmenNetherlandsRecruiting
Medisch Spectrum Twente
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EnschedeNetherlandsRecruiting
Groene Hart Ziekenhuis
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GoudaNetherlandsRecruiting
Martini Ziekenhuis
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GroningenNetherlandsRecruiting
Tjongerschans ziekenhuis
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HeerenveenNetherlandsRecruiting
Tergooi MC
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HilversumNetherlandsRecruiting
Dijklander Ziekenhuis
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HoornNetherlandsRecruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsRecruiting
Radboudumc
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NijmegenNetherlandsRecruiting
Bravis Ziekenhuis
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RoosendaalNetherlandsRecruiting
Maasstad Ziekenhuis
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RotterdamNetherlandsRecruiting
Franciscus Gasthuis & Vlietland
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SchiedamNetherlandsRecruiting
HagaZiekenhuis
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The HagueNetherlandsRecruiting
Haaglanden Medisch Centrum
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The HagueNetherlandsRecruiting
Elisabeth-Tweesteden Ziekenhuis
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TilburgNetherlandsRecruiting
UMC Utrecht
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UtrechtNetherlandsRecruiting
Diakonessenhuis
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UtrechtNetherlandsRecruiting
St. Antonius Ziekenhuis
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Utrecht & NieuwegeinNetherlandsRecruiting
Streekziekenhuis Koningin Beatrix
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WinterswijkNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.