The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
Recruiting · NCT06082492 · Interventional (participants receive a specific treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)
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 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
27 locations listed.
- Amsterdam UMC - Amsterdam, Netherlands
- Antoni van Leeuwenhoek/Nederlands Kanker Instituut - Amsterdam, Netherlands
- OLVG - Amsterdam, Netherlands
- Gelre Ziekenhuizen - Apeldoorn & Zutphen, Netherlands
- Amphia Ziekenhuis - Breda, Netherlands
- Deventer Ziekenhuis - Deventer, Netherlands
- Ziekenhuis Gelderse Vallei - Ede, Netherlands
- Máxima Medisch Centrum - Eindhoven & Veldhoven, Netherlands
- Treant - Emmen, Netherlands
- Medisch Spectrum Twente - Enschede, Netherlands
- Groene Hart Ziekenhuis - Gouda, Netherlands
- Martini Ziekenhuis - Groningen, Netherlands
- Tjongerschans ziekenhuis - Heerenveen, Netherlands
- Dijklander Ziekenhuis - Hoorn, Netherlands
- Canisius Wilhelmina Ziekenhuis - Nijmegen, Netherlands
- Radboudumc - Nijmegen, Netherlands
- Bravis Ziekenhuis - Roosendaal, Netherlands
- Maasstad ZIekenhuis - Rotterdam, Netherlands
- Franciscus Gasthuis & Vlietland - Schiedam, Netherlands
- Haaglanden Medisch Centrum - The Hague, Netherlands
- HagaZiekenhuis - The Hague, Netherlands
- Elisabeth-TweeSteden Ziekenhuis - Tilburg, Netherlands
- Diakonessenhuis - Utrecht, Netherlands
- UMC Utrecht - Utrecht, Netherlands
- St. Antonius Ziekenhuis - Utrecht & Nieuwegein, Netherlands
- Streekziekenhuis Koningin Beatrix - Winterswijk, Netherlands
- Tergooi MC - Hilversum, Utrecht, Netherlands