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

N/AActive Not RecruitingNCT03740126

Rigshospitalet, Denmark750 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

750

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Rigshospitalet

Copenhagen, Denmark

Gentofte Hospital

Gentofte Municipality, Denmark

Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Number of relapses treatable with curative intent

As decided by multidisciplinary meetings

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

Secondary Outcomes

Time to verified relapse

Relapse verified by histology or imaging combined with MDM review

Time frame: From date of randomization until the date of first documented relapse assessed up to 24 months

Overall survival

Death of any course or censoring

Time frame: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months

Overall survival for patients with relapse

Death of any course or censoring

Time frame: From randomization until 12 months after first detected relapse or until death (whichever comes first)

Performance status at relapse

Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".

Time frame: From randomization until first detected relapse or 24 months

Quality of life / QLQ-C30

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30). The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").

Time frame: From randomization until first detected relapse or 24 months

Quality of life / QLQ-LC13

Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13). The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").

Time frame: From randomization until first detected relapse or 24 months

Quality of life / Raw score

From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms. This will be used for calculation of QALY in the cost-effectiveness analysis.

Time frame: From randomization until first detected relapse or 24 months

Number of procedures to assess incidental findings

Procedures resulting from an incidental finding on a follow up scan

Time frame: From randomization until 24 months or first detected relapse or until death (whichever comes first)

Types of procedures to assess incidental findings

Invasive / non-invasive

Time frame: 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

For example: Bleeding, pneumothorax, hospital admission

Time frame: From randomization until 24 months or first detected relapse or until death (whichever comes first)

Cost-effectiveness analysis of intervention

Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years). Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise. Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs. The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.

Time frame: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)

Type of treatment after verification of relapse

Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment

Time frame: From randomization until 12 months after first detected relapse or until death (whichever comes first)