Trial Title:
The Beneficial Value of PET/CT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients
NCT ID:
NCT06082492
Condition:
Stage III Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Fluorodeoxyglucose F18
Conditions: Keywords:
18F FDG PET/CT scans
Follow-up care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F FDG PET/CT
Description:
Additional 18F FDG PET/CT scans during follow-up visits at 6, 12, 18, 24 and 36 months of
follow-up.
Arm group label:
Intervention group
Other name:
Whole body PET/CT scan
Intervention type:
Diagnostic Test
Intervention name:
CT scan
Description:
CT of the thoracic region during follow-up visits at 6, 12, 18, 24 and 36 months of
follow-up.
Arm group label:
Control group (care as usual)
Arm group label:
Intervention group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tergooi MC
Address:
City:
Hilversum
Zip:
1212 VG
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L. Kwast
Investigator:
Last name:
J. van Haarst, Dr.
Email:
Principal Investigator
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M. Smink
Investigator:
Last name:
A. Becker-Commissaris, Dr.
Email:
Principal Investigator
Facility:
Name:
Amphia Ziekenhuis
Address:
City:
Breda
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Research Longoncologie
Investigator:
Last name:
N. van Walree, Dr.
Email:
Principal Investigator
Facility:
Name:
Haaglanden Medisch Centrum
Address:
City:
Den Haag
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
E. Gortmaker
Investigator:
Last name:
K. Maas, Dr.
Email:
Principal Investigator
Facility:
Name:
HagaZiekenhuis
Address:
City:
Den Haag
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Research Longziekten
Investigator:
Last name:
P. Brocken, Dr.
Email:
Principal Investigator
Facility:
Name:
Deventer Ziekenhuis
Address:
City:
Deventer
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Research Oncologie
Investigator:
Last name:
R. Boshuizen, Dr.
Email:
Principal Investigator
Facility:
Name:
Treant
Address:
City:
Emmen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
T. Bokhorst
Investigator:
Last name:
S. Rutgers, Dr.
Email:
Principal Investigator
Facility:
Name:
Groene Hart Ziekenhuis
Address:
City:
Gouda
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
K. van Elst
Investigator:
Last name:
E. Geraedts, Dr.
Email:
Principal Investigator
Facility:
Name:
Martini Ziekenhuis
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
I. Jonker
Investigator:
Last name:
J. van Putten, Dr.
Email:
Principal Investigator
Facility:
Name:
Tjongerschans ziekenhuis
Address:
City:
Heerenveen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
H. Langenberg-Post
Investigator:
Last name:
M. de Vries, Dr.
Email:
Principal Investigator
Facility:
Name:
Dijklander Ziekenhuis
Address:
City:
Hoorn
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Y. van Dekken
Investigator:
Last name:
K. Mooij-Kalverda, Dr.
Email:
Principal Investigator
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Nicole E. Billingy, MSc.
Phone:
+31611469084
Email:
nicole.billingy@radboudumc.nl
Contact backup:
Last name:
NVALT31-PET Study Team
Phone:
+31611469084
Email:
nvalt31pet@radboudumc.nl
Investigator:
Last name:
I. Walraven, PhD.
Email:
Principal Investigator
Facility:
Name:
Bravis Ziekenhuis
Address:
City:
Roosendaal
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
J. Schellekens
Investigator:
Last name:
K. van Loenhout, Dr.
Email:
Principal Investigator
Facility:
Name:
Franciscus Gasthuis & Vlietland
Address:
City:
Schiedam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
S. Broerse
Investigator:
Last name:
J. Dits, Dr.
Email:
Principal Investigator
Facility:
Name:
Elisabeth-TweeSteden Ziekenhuis
Address:
City:
Tilburg
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A. Velthoven
Investigator:
Last name:
M. Schiefer, Dr.
Email:
Principal Investigator
Facility:
Name:
St. Antonius Ziekenhuis
Address:
City:
Utrecht & Nieuwegein
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
R&D Longoncologie
Investigator:
Last name:
L. Kastelijn, Dr.
Email:
Principal Investigator
Facility:
Name:
Diakonessenhuis
Address:
City:
Utrecht
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Research Oncologie
Investigator:
Last name:
K. Dr. K. Schulkes, Dr.
Email:
Principal Investigator
Start date:
March 19, 2024
Completion date:
June 2029
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
Streekziekenhuis Koningin Beatrix
Agency class:
Other
Collaborator:
Agency:
Canisius-Wilhelmina Hospital
Agency class:
Other
Collaborator:
Agency:
Diakonessenhuis, Utrecht
Agency class:
Other
Collaborator:
Agency:
Dijklander Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Deventer Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Elisabeth-TweeSteden Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Gelre Hospitals
Agency class:
Other
Collaborator:
Agency:
Groene Hart Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
HagaZiekenhuis
Agency class:
Other
Collaborator:
Agency:
Martini Hospital Groningen
Agency class:
Other
Collaborator:
Agency:
Medisch Spectrum Twente
Agency class:
Other
Collaborator:
Agency:
St. Antonius Hospital
Agency class:
Other
Collaborator:
Agency:
Franciscus &Vlietland
Agency class:
Other
Collaborator:
Agency:
Tjongerschans
Agency class:
Other
Collaborator:
Agency:
Maasstadziekenhuis
Agency class:
Other
Collaborator:
Agency:
Gelderse Vallei Hospital
Agency class:
Other
Collaborator:
Agency:
Bravis Hospital
Agency class:
Other
Collaborator:
Agency:
Tergooi Hospital
Agency class:
Other
Collaborator:
Agency:
Treant Zorggroep
Agency class:
Other
Collaborator:
Agency:
Amphia Hospital
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
OLVG
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Antoni van Leeuwenhoek Hospital
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082492
