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.
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
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.
Parallel
18F FDG PET/CT
Diagnostic testAdditional 18F FDG PET/CT scans during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
CT scan
Diagnostic testCT of the thoracic region during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
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.
Number of detected symptomatic and asymptomatic recurrences
As seen on a scan and/or confirmed by biopsy
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
Amsterdam UMC, location VUmc
Collaborator
Streekziekenhuis Koningin Beatrix
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Diakonessenhuis, Utrecht
Collaborator
Dijklander Ziekenhuis
Collaborator
Deventer Ziekenhuis
Collaborator
Elisabeth-TweeSteden Ziekenhuis
Collaborator
Gelre Hospitals
Collaborator
Groene Hart Ziekenhuis
Collaborator
HagaZiekenhuis
Collaborator
Martini Hospital Groningen
Collaborator
Medisch Spectrum Twente
Collaborator
St. Antonius Hospital
Collaborator
Franciscus &Vlietland
Collaborator
Tjongerschans
Collaborator
Maasstadziekenhuis
Collaborator
Gelderse Vallei Hospital
Collaborator
Bravis Hospital
Collaborator
Tergooi Hospital
Collaborator
Treant Zorggroep
Collaborator
Amphia Hospital
Collaborator
UMC Utrecht
Collaborator
OLVG
Collaborator
Haaglanden Medical Centre
Collaborator
Antoni van Leeuwenhoek Hospital
Collaborator
