Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy (SUPE_R)

Rigshospitalet

Status: Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Diagnostic Test: Whole body 18F-FDG PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03740126

H-18009536

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Arm A, PET/CT

Experimental group

Description:

18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21. Quality of life assessment and liquid biopsy every 3 months for later analysis.

Treatment:

Diagnostic Test: Whole body 18F-FDG PET/CT

Control arm B

No Intervention group

Description:

CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.