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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Antoni van Leeuwenhoek/Nederlands Kanker Instituut
RECRUITING
Amsterdam
OLVG
RECRUITING
Amsterdam
Gelre Ziekenhuizen
RECRUITING
Apeldoorn & Zutphen
Amphia Ziekenhuis
RECRUITING
Breda
Deventer Ziekenhuis
RECRUITING
Deventer
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
Máxima Medisch Centrum
RECRUITING
Eindhoven & Veldhoven
Treant
RECRUITING
Emmen
Medisch Spectrum Twente
RECRUITING
Enschede
Groene Hart Ziekenhuis
RECRUITING
Gouda
Martini Ziekenhuis
RECRUITING
Groningen
Tjongerschans ziekenhuis
RECRUITING
Heerenveen
Tergooi MC
RECRUITING
Hilversum
Dijklander Ziekenhuis
RECRUITING
Hoorn
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboudumc
RECRUITING
Nijmegen
Bravis Ziekenhuis
RECRUITING
Roosendaal
Maasstad ZIekenhuis
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland
RECRUITING
Schiedam
Haaglanden Medisch Centrum
RECRUITING
The Hague
HagaZiekenhuis
RECRUITING
The Hague
Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
Diakonessenhuis
RECRUITING
Utrecht
UMC Utrecht
RECRUITING
Utrecht
St. Antonius Ziekenhuis
RECRUITING
Utrecht & Nieuwegein
Streekziekenhuis Koningin Beatrix
RECRUITING
Winterswijk
Contact Information
Primary
NVALT31-PET study team
NVALT31PET@radboudumc.nl
+31611469084
Backup
Nicole E. Billingy, MSc.
nicole.billingy@radboudumc.nl
+31611469084
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2029-06
Participants
Target number of participants: 690
Treatments
Experimental: Intervention group
The 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).
Active_comparator: Control group (care as usual)
The 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
Sponsors
Collaborators: Deventer Ziekenhuis, Elisabeth-TweeSteden Ziekenhuis, HagaZiekenhuis, Amphia Hospital, Amsterdam UMC, location VUmc, Dijklander Ziekenhuis, Tjongerschans, Maasstadziekenhuis, Franciscus &Vlietland, Haaglanden Medical Centre, Gelderse Vallei Hospital, Groene Hart Ziekenhuis, UMC Utrecht, Antoni van Leeuwenhoek Hospital, Bravis Hospital, Medisch Spectrum Twente, Gelre Hospitals, St. Antonius Hospital, Martini Hospital Groningen, Canisius-Wilhelmina Hospital, Treant Zorggroep, Diakonessenhuis, Utrecht, Tergooi Hospital, OLVG, Streekziekenhuis Koningin Beatrix
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov