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

Recruiting now · Not applicable

Conditions studied: Stage III Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06082492

Run by

Radboud University Medical Center

People needed

690

Starts

2024-03-19

Expected to finish

2029-06-01

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)

You may not qualify if…

• 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.

Where it is running

• Tergooi MC — Hilversum, Utrecht, Netherlands (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)
• Antoni van Leeuwenhoek/Nederlands Kanker Instituut — Amsterdam, Netherlands (enrolling)
• OLVG — Amsterdam, Netherlands (enrolling)
• Gelre Ziekenhuizen — Apeldoorn & Zutphen, Netherlands (enrolling)
• Amphia Ziekenhuis — Breda, Netherlands (enrolling)
• Deventer Ziekenhuis — Deventer, Netherlands (enrolling)
• Ziekenhuis Gelderse Vallei — Ede, Netherlands (enrolling)
• Máxima Medisch Centrum — Eindhoven & Veldhoven, Netherlands (enrolling)
• Treant — Emmen, Netherlands (enrolling)
• Medisch Spectrum Twente — Enschede, Netherlands (enrolling)
• Groene Hart Ziekenhuis — Gouda, Netherlands (enrolling)
• Martini Ziekenhuis — Groningen, Netherlands (enrolling)
• Tjongerschans ziekenhuis — Heerenveen, Netherlands (enrolling)
• Dijklander Ziekenhuis — Hoorn, Netherlands (enrolling)
• Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (enrolling)
• Radboudumc — Nijmegen, Netherlands (enrolling)
• Bravis Ziekenhuis — Roosendaal, Netherlands (enrolling)
• Maasstad ZIekenhuis — Rotterdam, Netherlands (enrolling)
• Franciscus Gasthuis & Vlietland — Schiedam, Netherlands (enrolling)
• Haaglanden Medisch Centrum — The Hague, Netherlands (enrolling)
• HagaZiekenhuis — The Hague, Netherlands (enrolling)
• Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (enrolling)
• Diakonessenhuis — Utrecht, Netherlands (enrolling)
• UMC Utrecht — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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