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
Radboud University Medical Center
690 participants
Mar 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
- 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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)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 Criteria4
- 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.
Interventions
Additional 18F FDG PET/CT scans during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
CT of the thoracic region during follow-up visits at 6, 12, 18, 24 and 36 months of follow-up.
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT06082492