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

1. april 2022 opdateret af: Barbara Malene Fischer, Rigshospitalet, Denmark

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

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

750

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • Rigshospitalet
      • Gentofte, Danmark, 2900
        • Gentofte Hospital
      • Herlev, Danmark, 2730
        • Herlev Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A, PET/CT
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.
Diagnostisk test: Whole body 18F-FDG PET/CT
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.
Ingen indgriben: Control arm B
CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of relapses treatable with curative intent
Tidsramme: Until first detected relapse or 2 years after enrollment
As decided by multidisciplinary meetings
Until first detected relapse or 2 years after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to verified relapse
Tidsramme: From date of randomization until the date of first documented relapse assessed up to 24 months
Relapse verified by histology or imaging combined with MDM review
From date of randomization until the date of first documented relapse assessed up to 24 months
Overall survival
Tidsramme: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months
Death of any course or censoring
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
Tidsramme: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Death of any course or censoring
From randomization until 12 months after first detected relapse or until death (whichever comes first)
Performance status at relapse
Tidsramme: From randomization until first detected relapse or 24 months
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".
From randomization until first detected relapse or 24 months
Quality of life / QLQ-C30
Tidsramme: From randomization until first detected relapse or 24 months

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").
From randomization until first detected relapse or 24 months
Quality of life / QLQ-LC13
Tidsramme: From randomization until first detected relapse or 24 months

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").
From randomization until first detected relapse or 24 months
Quality of life / Raw score
Tidsramme: From randomization until first detected relapse or 24 months
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.
From randomization until first detected relapse or 24 months
Number of procedures to assess incidental findings
Tidsramme: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Procedures resulting from an incidental finding on a follow up scan
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Types of procedures to assess incidental findings
Tidsramme: From randomization until 24 months or first detected relapse or until death (whichever comes first)
Invasive / non-invasive
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
Tidsramme: From randomization until 24 months or first detected relapse or until death (whichever comes first)
For example: Bleeding, pneumothorax, hospital admission
From randomization until 24 months or first detected relapse or until death (whichever comes first)
Cost-effectiveness analysis of intervention
Tidsramme: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first)
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.
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
Tidsramme: From randomization until 12 months after first detected relapse or until death (whichever comes first)
Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment
From randomization until 12 months after first detected relapse or until death (whichever comes first)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rigshospitalet, Denmark

Samarbejdspartnere

Danish Lung Cancer Group
Danish Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Barbara M Fischer, MD PhD DMSci, Rigshospitalet, Denmark

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. oktober 2018

Primær færdiggørelse (Forventet)

1. august 2023

Studieafslutning (Forventet)

1. august 2026

Datoer for studieregistrering

Først indsendt

25. oktober 2018

Først indsendt, der opfyldte QC-kriterier

12. november 2018

Først opslået (Faktiske)

14. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-18009536

Plan for individuelle deltagerdata (IPD)

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