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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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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 disease, early detection of tumor recurrence can prolong survival and health-related quality of life and thereby lower the disease burden. With the use of 18F FDG PET/CT during follow-up, recurrences may be detected earlier at an oligometastatic state when curative-intent treatment is still possible.

Primary objective:

\- 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 FDG PET/CT versus follow-up with conventional CT surveillance.

The secondary objectives of this study are:

* To compare the 2-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance (interim analysis);
* To compare the number of detected (symptomatic and asymptomatic) recurrences of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;
* To compare the event-free survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT-based surveillance;
* To determine the cost-effectiveness of 18F FDG PET/CT versus conventional CT-based surveillance during follow-up of stage III NSCLC patients;
* To compare the effect of 18F FDG PET/CT versus conventional CT-based surveillance on health-related quality of life during follow-up of stage III NSCLC patients;
* To assess the beneficial value of ctDNA in the detection of recurrences during follow-up in stage III NSCLC patients;
* To identify patients' experiences with the additional 18F FDG PET/CT scans in the follow-up of stage III NSCLC patients.
* To assess differences in type of treatment following recurrence during follow-up in stage III NSCLC patients.

Primary analyses will be performed on an intention-to-treat basis as well as per protocol. Kaplan-Meier curves with stratified log-rank 2-sided tests will be used to compare the survival between groups. In case of empty strata, strata will be collapsed. The clinical relevance of the difference will be primarily expressed in terms of 3-year survival of the intervention versus the control group.

Conditions

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Stage III Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multicenter randomized controlled clinical trial with a superiority design. At approximately 4 months after the end of curative intent treatment patients will be randomized 1:1 to either the intervention (18F FDG PET/CT) or the control group (usual care, CT-based follow-up). Randomization will be done stratifying for histology and treatment.

After the start of the study all patients will have regular follow-up visits at 6, 12, 18, 24 months and 36 months after the end of curative intent treatment, as is stated in the Dutch guidelines. In the intervention group these visits will be complemented by a 18F FDG PET/CT scan, while in the control group the visits will only contain a CT scan.

For patients in the intervention group who give consent for participation in the collection of blood, blood will be drawn around the scan.

At all time points patients will be asked to fill in the HRQOL and cost-effectiveness questionnaires.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention group

The intervention group (n = 345) consists of usual care until 3 years of follow-up (see comparator) with additional whole-body 18F FDG PET/CT scans (from the skull to, at least, the midfemoral region) during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up. After the 36-month follow-up period, patients will receive follow-up usual care (i.e. CT-scans).

The scanning protocol of Boellaard et al (2015) is the basis of all center-specific protocols and therefore will be followed approximately (PET low dose CT 60 minutes post injection with scan trajectory from skull to (at least the) thighs followed by a CT scan).

Group Type EXPERIMENTAL