Clinical trial NCT06082492: The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage III Non-small Cell Lung Cancer
Keywords: 18F FDG PET/CT scans
Follow-up care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Streekziekenhuis Koningin Beatrix
name: Canisius-Wilhelmina Hospital
name: Diakonessenhuis, Utrecht
name: Dijklander Ziekenhuis
name: Deventer Ziekenhuis
name: Elisabeth-TweeSteden Ziekenhuis
name: Gelre Hospitals
name: Groene Hart Ziekenhuis
name: HagaZiekenhuis
name: Martini Hospital Groningen
name: Medisch Spectrum Twente
name: St. Antonius Hospital
name: Franciscus &Vlietland
name: Tjongerschans
name: Maasstadziekenhuis
name: Gelderse Vallei Hospital
name: Bravis Hospital
name: Tergooi Hospital
name: Treant Zorggroep
name: Amphia Hospital
name: UMC Utrecht
name: OLVG
name: Haaglanden Medical Centre
name: Antoni van Leeuwenhoek Hospital
First posted: 2023-10-13
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.

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 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.

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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 years after end of curative intent treatment
Secondary outcomes:
measure: Number of detected symptomatic and asymptomatic recurrences
timeFrame: Up to 3 years after end of curative intent treatment
measure: Event-free survival (EFS)
timeFrame: 3 years after end of curative intent treatment
measure: Quality-adjusted life-years ((QALY's) for the cost-effectiveness analysis (CEA))
timeFrame: Up to 3 years after end of curative intent treatment
measure: Hospital and medical resource use (for the CEA)
timeFrame: Up to 3 years after end of curative intent treatment
measure: Productivity losses (for the CEA)
timeFrame: Up to 3 years after end of curative intent treatment
measure: Health-related quality of life (HRQOL)
timeFrame: Up to 3 years after end of curative intent treatment collected around the follow-up scans.
measure: Patients' evaluation of the 18F FDG PET/CT scans
timeFrame: Up to 3 years after end of curative intent treatment collected around the follow-up scans.
measure: Blood samples
timeFrame: Up to 3 years after end of curative intent treatment collected around the follow-up scans.
Other outcomes:
Locations:
city: Hilversum
country: Netherlands
facility: Tergooi MC
state: Utrecht
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek/Nederlands Kanker Instituut
city: Amsterdam
country: Netherlands
facility: OLVG
city: Apeldoorn & Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven & Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
city: Emmen
country: Netherlands
facility: Treant
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Heerenveen
country: Netherlands
facility: Tjongerschans ziekenhuis
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad ZIekenhuis
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Utrecht & Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Winterswijk
country: Netherlands
facility: Streekziekenhuis Koningin Beatrix
Study officials:
affiliation: Radboud University Medical Center
name: Iris Walraven, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Annemarie Becker-Commissaris, PhD./MD.
role: PRINCIPAL_INVESTIGATOR
References: