Using PET/CT scans to improve follow-up care for stage III lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of 18F-Fluorodeoxyglucose Positron Emission Tomography/Computerized Tomography (18F FDG PET/CT) scans in improving the 3-year overall survival of patients with stage III non-small cell lung cancer (NSCLC) during follow-up care. Participants will be divided into two groups: one receiving standard follow-up care with conventional CT scans and the other receiving additional 18F FDG PET/CT scans at specified intervals. The study will also assess the cost-effectiveness of this imaging approach and gather quality of life data through questionnaires and optional interviews. The goal is to determine if earlier detection of recurrences can lead to better treatment outcomes.

Why it matters

Who can join: the full rules

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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)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

Where it's running

• Tergooi MC
  Hilversum, Utrecht, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Antoni van Leeuwenhoek/Nederlands Kanker Instituut
  Amsterdam, Netherlands Recruiting
• Olvg
  Amsterdam, Netherlands Recruiting
• Gelre Ziekenhuizen
  Apeldoorn & Zutphen, Netherlands Recruiting
• Amphia Ziekenhuis
  Breda, Netherlands Recruiting

Study contacts

• Principal investigator: Iris Walraven, PhD. — Radboud University Medical Center
• Study coordinator: NVALT31-PET study team
• Email: NVALT31PET@radboudumc.nl
• Phone: +31611469084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.