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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 aprile 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

750

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Test diagnostico: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of relapses treatable with curative intent
Lasso di tempo: Until first detected relapse or 2 years after enrollment
As decided by multidisciplinary meetings
Until first detected relapse or 2 years after enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to verified relapse
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rigshospitalet, Denmark

Collaboratori

Danish Lung Cancer Group
Danish Comprehensive Cancer Center

Investigatori

  • Investigatore principale: Barbara M Fischer, MD PhD DMSci, Rigshospitalet, Denmark

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 ottobre 2018

Completamento primario (Anticipato)

1 agosto 2023

Completamento dello studio (Anticipato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

25 ottobre 2018

Primo inviato che soddisfa i criteri di controllo qualità

12 novembre 2018

Primo Inserito (Effettivo)

14 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-18009536

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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