NCT06082492Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 690 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 19 Mar 2024
- Primary completion date
- Apr 2029
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Lung cancer
- NCT number
- NCT06082492
What you commit to
- Study type: Interventional
- Planned participants: 690
- From 19 Mar 2024 to the primary completion date, Apr 2029
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.
Other
- 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)
Who the study is looking for
- 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)
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Antoni Van Leeuwenhoek (Nederlands Kanker Instituut) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Gelre Ziekenhuizen Coordinator of this site? Confirm its status | Apeldoorn & Zutphen | Netherlands | Recruiting |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Recruiting |
| Ziekenhuis Gelderse Vallei Coordinator of this site? Confirm its status | Ede | Netherlands | Recruiting |
| Máxima Medisch Centrum Coordinator of this site? Confirm its status | Eindhoven & Veldhoven | Netherlands | Recruiting |
| Treant Coordinator of this site? Confirm its status | Emmen | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| Groene Hart Ziekenhuis Coordinator of this site? Confirm its status | Gouda | Netherlands | Recruiting |
| Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Tjongerschans ziekenhuis Coordinator of this site? Confirm its status | Heerenveen | Netherlands | Recruiting |
| Tergooi MC Coordinator of this site? Confirm its status | Hilversum | Netherlands | Recruiting |
| Dijklander Ziekenhuis Coordinator of this site? Confirm its status | Hoorn | Netherlands | Recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Bravis Ziekenhuis Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Recruiting |
| Maasstad Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Franciscus Gasthuis & Vlietland Coordinator of this site? Confirm its status | Schiedam | Netherlands | Recruiting |
| HagaZiekenhuis Coordinator of this site? Confirm its status | The Hague | Netherlands | Recruiting |
| Haaglanden Medisch Centrum Coordinator of this site? Confirm its status | The Hague | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Diakonessenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Utrecht & Nieuwegein | Netherlands | Recruiting |
| Streekziekenhuis Koningin Beatrix Coordinator of this site? Confirm its status | Winterswijk | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.