NCT06082492 The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
| NCT ID | NCT06082492 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Stage III Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 690 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 690 participants in total. It began in 2024-03-19 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. 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.
Contact & Investigator
Iris Walraven, PhD.
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT06082492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage III Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082492 currently recruiting?
Yes, NCT06082492 is actively recruiting participants. Contact the research team at NVALT31PET@radboudumc.nl for enrollment information.
Where is the NCT06082492 trial being conducted?
This trial is being conducted at Hilversum, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands and 11 additional locations.
Who is sponsoring the NCT06082492 clinical trial?
NCT06082492 is sponsored by Radboud University Medical Center. The principal investigator is Iris Walraven, PhD. at Radboud University Medical Center. The trial plans to enroll 690 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.