Clinical trial NCT03740126: Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy
Official title: Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Positron Emission Tomography Computed Tomography
X-Ray Computed Tomography
Liquid Biopsy
Quality of Life
Medical Oncology
Radiation Oncology
Follow-up
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Lung Cancer Group
name: Danish Comprehensive Cancer Center
First posted: 2018-11-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized controlled trial
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Number of relapses treatable with curative intent
timeFrame: Until first detected relapse or 2 years after enrollment
Secondary outcomes:
measure: Time to verified relapse
timeFrame: From date of randomization until the date of first documented relapse assessed up to 24 months
measure: Overall survival
timeFrame: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
measure: Overall survival for patients with relapse
timeFrame: From randomization until 12 months after first detected relapse or until death (whichever comes first)
measure: Performance status at relapse
timeFrame: From randomization until first detected relapse or 24 months
measure: Quality of life / QLQ-C30
timeFrame: From randomization until first detected relapse or 24 months
measure: Quality of life / QLQ-LC13
timeFrame: From randomization until first detected relapse or 24 months
measure: Quality of life / Raw score
timeFrame: From randomization until first detected relapse or 24 months
measure: Number of procedures to assess incidental findings
timeFrame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
measure: Types of procedures to assess incidental findings
timeFrame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
measure: Adverse events due to invasive procedures done to assess incidental findings
timeFrame: From randomization until 24 months or first detected relapse or until death (whichever comes first)
measure: Cost-effectiveness analysis of intervention
timeFrame: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
measure: Type of treatment after verification of relapse
timeFrame: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Gentofte
country: Denmark
facility: Gentofte Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Barbara M Fischer, MD PhD DMSci
role: PRINCIPAL_INVESTIGATOR
References: