Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial

Rigshospitalet, Denmark3 sites in 1 country750 target enrollmentOctober 25, 2018

ConditionsCarcinoma, Non-Small-Cell Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Rigshospitalet, Denmark
Enrollment: 750
Locations: 3
Primary Endpoint: Number of relapses treatable with curative intent
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.

Registry

clinicaltrials.gov

Start Date

October 25, 2018

End Date

August 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Responsible Party

Principal Investigator

Barbara Malene Fischer

Senior Consultant, Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

•Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
•Patient in clinical stages I-III
•Age≥ 18 years
•Performance status ≤ 2 at the time of referral to therapy
•Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
•Patient has given his/her written informed consent before any specific procedure from protocol

Exclusion Criteria

•Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
•Persons deprived of liberty or under guardianship or curators
•Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
•Pregnant or breastfeeding women
•Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.

Outcomes

Primary Outcomes

Number of relapses treatable with curative intent

Time Frame: Until first detected relapse or 2 years after enrollment

As decided by multidisciplinary meetings

Secondary Outcomes

Quality of life / QLQ-C30(From randomization until first detected relapse or 24 months)
Quality of life / QLQ-LC13(From randomization until first detected relapse or 24 months)
Quality of life / Raw score(From randomization until first detected relapse or 24 months)
Overall survival(From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months)
Time to verified relapse(From date of randomization until the date of first documented relapse assessed up to 24 months)
Number of procedures to assess incidental findings(From randomization until 24 months or first detected relapse or until death (whichever comes first))
Adverse events due to invasive procedures done to assess incidental findings(From randomization until 24 months or first detected relapse or until death (whichever comes first))
Type of treatment after verification of relapse(From randomization until 12 months after first detected relapse or until death (whichever comes first))
Overall survival for patients with relapse(From randomization until 12 months after first detected relapse or until death (whichever comes first))
Performance status at relapse(From randomization until first detected relapse or 24 months)
Types of procedures to assess incidental findings(From randomization until 24 months or first detected relapse or until death (whichever comes first))
Cost-effectiveness analysis of intervention(From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first))