Status:

RECRUITING

The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients

Lead Sponsor:

Radboud University Medical Center

Collaborating Sponsors:

Amsterdam UMC, location VUmc

Streekziekenhuis Koningin Beatrix

Conditions:

Stage III Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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/ Comput...

Detailed Description

Stage III non-small cell lung cancer (NSCLC) patients are at high risk of developing recurrences (50-78%) during follow-up. With more effective treatments available for patients with oligometastatic d...

Eligibility Criteria

Inclusion

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and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)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

  • 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.

Key Trial Info

Start Date :

March 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2029

Estimated Enrollment :

690 Patients enrolled

Trial Details

Trial ID

NCT06082492

Start Date

March 19 2024

End Date

June 1 2029

Last Update

February 5 2025

Active Locations (27)

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Page 1 of 7 (27 locations)

1

Tergooi MC

Hilversum, Utrecht, Netherlands, 1212 VG

2

Amsterdam UMC

Amsterdam, Netherlands

3

Antoni van Leeuwenhoek/Nederlands Kanker Instituut

Amsterdam, Netherlands

4

OLVG

Amsterdam, Netherlands